A DEMONSTRATION PROJECT WITH A FOCUS ON MICROORGANISMS
FINAL REPORT ON THE GBRCN
DEMONSTRATION PROJECT
Period of Project:
30.11. 2008 - 30.11. 2011
ISBN 978-3-00-038121-8
RECIPIENT OF FUNDS:
DSMZ - GERMAN COLLECTION OF MICROORGANISMS AND CELL CULTURES
INHOFFENSTRASSE 7B, 38124 BRAUNSCHWEIG, GERMANY
REFERENCE CODE:
1GP0901
PROJECT:
DEMONSTRATION PROJECT FOR A GLOBAL NETWORK FOR
BIOLOGICAL RESOURCE CENTRES GBRCN - ACCORDING TO OECD
PLACE:
C/O DSMZ - GERMAN COLLECTION OF MICROORGANISMS AND CELL CULTURES
INHOFFENSTRASSE 7B, 38124 BRAUNSCHWEIG, GERMANY
AUTHORS:
GBRCN DEMONSTRATION PROJECT SECRETARIAT
ISBN 978-3-00-038121-8
LAYOUT:
ZWEI & EINZ – RAUM FÜR GESTALTUNG: MATTHIAS BAYER, HOCHSTRASSE 16, 38102 BRAUNSCHWEIG
PRINT:
BEYRICH DIGITALSERVICE GMBH & CO. KG, BÜLTENWEG 73, 38106 BRAUNSCHWEIG
Final Report on the GBRCN Demonstration Project
PREAMBLE
PREAMBLE
Biological resources, such as microorganisms and their derivatives, are the essential raw
material for the advancement of human health, food security, biotechnology - the grand
challenges of the future -, and research and development in all Life Sciences. They represent a hitherto untapped rich source. It is estimated that only a minute fraction (<0.1%) of
the existing microbial diversity is known today; and of this, only a small proportion of living
cultures have been deposited in ex-situ collections and are available for immediate study.
However, global scientific progress and the
resulting growth of the knowledge-based
bio-economy will depend on the broadest
possible availability of such biological materials. And, as their study in-situ is not possible,
it will also depend on the facilitated and safe
access to the ex-situ held cultures of the living
microbial diversity and their derived data.
Alfred Oberholz, Degussa AG
To appropriately support the more and more
cooperative, globalised research and development, both, the biological material and the related data, need to be of adequate and
comparable quality world-wide. This will require coordinated policy actions put in place
by governments.
White biotech is the third wave in the
field of biotechnology: it follows the red
and green applications. It means employing the life sciences and biotechnology in
the production process itself to find more
efficient and sustainable ways of manufacturing products.
A Global Biological Resource Centre Network (GBRCN) being explored by the GBRCN
Demonstration Project would provide an appropriate infrastructure ensuring the favourable environment for such development. Based on the idea of the transition of classical service culture collections to Biological Resource Centres (BRCs), and such centres
working according to overall acknowledged Best Practice and commonly agreed procedures and principles, this global infrastructure will enable and greatly enhance:
2
•
global collaboration in research and collaboration between BRCs, their user communities,
relevant regulatory bodies and funding bodies
•
addressing scientific challenges, such as diminishing taxonomic and systematic expertise
PREAMBLE
•
development of innovative solutions to major global problems, such as health, food security,
climate change
•
harmonisation of legislation compliance on the national, regional and global levels
•
development of operational frameworks to facilitate safe access to biological materials and
information (including CBD-ABS)
•
development of common policies on biosafety / biosecurity / biorisk issues
•
coordinating and focussing activities on resource and service provision towards key user
demands
•
cross discipline cooperation with similar initiatives to foster synergies
Access to Resources and Services will Drive Innovation and Accelerate Discovery
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
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Final Report on the GBRCN Demonstration Project
TABLE OF CONTENTS
TABLE OF CONTENTS
I.
PREAMBLE
2
EXECUTIVE SUMMARY
6
II. RECOMMENDATIONS
III. WORK PACKAGES
10
1. WORK PACKAGE 1: MANAGEMENT OF THE PROJECT, OUTREACH AND COMMUNICATION
10
2. WORK PACKAGE 2: BRC QUALITY MANAGEMENT AND IMPLEMENTING COMMON STANDARDS
AND PROTOCOLS
19
3. WORK PACKAGE 3: COMMON APPROACHES EXPLORED TO IMPLEMENT AGREED PRINCIPLES
ON BIOSAFETY, BIOSECURITY, RISK ASSESSMENT, OWNERSHIP AND MANAGEMENT OF
IP ENFORCED BY EXISTING NATIONAL, REGIONAL AND GLOBAL LEGISLATION
26
4. WORK PACKAGE 4: THE BRC AND THE NETWORK LONG-TERM SUSTAINABILITY
34
5. WORK PACKAGE 5: CAPACITY BUILDING IN INFORMATION TECHNOLOGY
39
6. WORK PACKAGE 6: DEVELOPMENT OF ADDITIONAL, SUPPORTING PROJECTS
43
IV. OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
4
8
49
1. IMPLEMENTATION OF BEST PRACTICES AND CAPACITY BUILDING
49
2. DATA RESOURCES AND INFORMATION SYSTEMS
49
3. LEGISLATION COMPLIANCE AND OPERATIONAL FRAMEWORK
50
4. FINANCES AND SUSTAINABILITY
51
5. OUTREACH
52
V. THE GBRCN DEMONSTRATION PROJECT PARTNERSHIP
58
VI. GLOSSARY
60
VII. ANNEX
62
APPLIED SCIENCES FOR BIOECONOMY
Biological systems and their applications
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
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EXECUTIVE SUMMARY
I. EXECUTIVE SUMMARY
Developing a Concept for a Global Biological Resource Centre Network
The GBRCN Demonstration Project is a response to the OECD initiative on Biological
Resource Centres. A Task Force, including experts from OECD and Non-OECD countries,
recommended that governments, scientific policy makers and other stakeholders should
implement policies to ensure that high quality biological material is made available for
research and development worldwide, and that the challenges of safe and legitimate
access to it are tackled. Five main points of action were formulated: • establish national
BRCs • develop an accreditation system for BRCs based on international criteria • create
international linkages among BRCs • coordinate standards, rules and regulations, taking
BRCs into account • establish a global BRC network.
Driven by the general recognition that scientific infrastructures are needed to support
research, the goals of the Demonstration Project were defined to embrace the establishment of a model GBRCN with clear positioning of the network differentiated from existing
cooperative networks and organisations, its implementation, the development of national
certification processes and assessment of OECD Best Practice Guidelines for BRCs.
The project was made possible through the joint efforts of the German Federal Ministry
for Science and Education (BMBF) on one side, who funded the coordinating project secretariat, and on the other side by the dedicated efforts of 15 partners worldwide (including
the initial partners and one joining later), who contributed to the outcomes of the project
at their own expense.
In the course of the project period, a strategy for setting up a GBRCN, an outline of its
organizational structures and funding were developed as well as potential staffing and
the identification of key elements of its activities. At the same time a number of issues of
relevance for the practical day-to-day management of BRCs were exemplarily tackled.
6
EXECUTIVE SUMMARY
It was concluded that for such a global research infrastructure stratified approaches would
be necessary linking the global, regional and national levels enabling cross-fertilisation.
Consensus was reached among partners that such an infrastructure needs to be science
driven and based on bottom-up activities, but that these could only be viable when accompanied and supported by clear commitment from governments. Emphasis was laid on the
fact that funding of a research infrastructure should be more closely connected to the
funding of the research it should serve, and competition avoided.
A general model for a cooperation structure was developed including a legally nonbinding Memorandum of Understanding,
to be signed by cooperating governments,
and a Cooperation Agreement, to be signed
by the cooperating entities. A Secretariat
structure, requirements for the hosting
institution and country, together with their
mutual rights and duties, has been laid
down besides other operational elements.
It will be a complex political process that will
need considerable governmental involvement
to achieve a system acceptable and beneficial
to all, and, obviously, a great deal will depend
on the governance system that is in place for
the final network.
Malcolm Dando, University Bradford
(2010, Bulletin of the Atomic Scientist)
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RECOMMENDATIONS
II. RECOMMENDATIONS
Architecture and Governance
1. The structure of global interaction of the future GBRCN should take into consideration
•
a stratified approach that links at the global, regional and national levels
•
to link mandated BRCs and their networks with non-mandated, voluntary regulated collections
and their networks
•
to connect to governing and regulatory bodies
2. The various regional and national initiatives should be effectively reconciled so that
progress is not hampered and unnecessary duplication is avoided
3.
Working groups, projects or clusters should be established for the various key areas and
tasks to facilitate culture collection transition to become BRCs and their adoption of the
excellence model
Sustainability
4. Secured long-term core funding is a prerequisite for the long-term duties of a GBRCN
secretariat
5.
To render the GBRCN viable and sustainable, structured, matching funding should be
sought (see WP4 for more details)
•
potential sources of funding are, as appropriate, structural, governmental, development and
research funds
— sourced from global, regional or national levels and specific budgets should be assigned to:
› the collaborating entities
› the network functioning
› the coordinating secretariat
6.
Associated core seed money should be secured to trigger activities at BRCs, which otherwise would be difficult to fund by the normal research funding mechanisms; e.g. authentication of holdings of BRCs, or applying appropriate preservation methods
7.
Matching short-term funded projects should be sought for particular activities to enhance
development
•
in individual countries
•
in individual regions
•
for activities of global relevance such as the web portal
8. Funding agencies should be advised that research infrastructures should not have to
compete for funding with the research they are meant to serve; both activities should be
better linked to each other for mutual benefit
9.
The instruments of establishment developed in the GBRCN Demonstration Project contain
relevant financial aspects and should be used to establish the GBRCN
10. The GBRCN business plan should be modified taking into account deliberations in regional
efforts such as MIRRI
11. The generic business plan should be adapted to suit national and individual BRC needs and
the funding mechanisms available to them
Scientific quality, management and capacity building
12. The remit of a GBRCN should be clearly science based, user community orientated and
service driven
8
RECOMMENDATIONS
13. The goals and the collaboration in GBRCN should be firmly based on quality of resources,
data and services rendered to research and development and the related capacity
building
14. Capacity building tools should be established to facilitate the establishment and operation of quality management and the implementation of the OECD best practice guidelines
at BRCs
15. Capacity building programmes should be established to address the scientific and technical needs, including laboratory work, systematic / taxonomic techniques, etc as a necessary basis for overall quality
Information resource
16. The future GBRCN should establish an information system that encompasses
•
addressing all user groups: BRCs, science, industrial R+D, commercial users, policy makers
•
worldwide accessibility to information and biological material
•
worldwide linkage to open up opportunities and to provide rapid access to expertise
•
network strategy to
— eliminate the limitations on information flow
— provide one-stop access to pertinent information and biomaterials
•
facilities providing a resource for public information and policy formulation
•
interoperability with other data sources to facilitate access and use of microbial resources
•
synergies with existing data providing initiatives
17. The future GBRCN information system should offer benefits and user driven added value
for all user groups – embedded in continuous quality management and strong policy;
giving all providers and users confidence and trust in the global virtual institution GBRCN
is offering
Compliance with legislation
18. The Biosecurity Code of Conduct for BRCs is an accompaniment to the GBRCN Cooperation
Agreement and is open to be adopted by all culture collection/BRC organisations, networks
or research infrastructures
19. The GBRCN as a whole and BRCs specifically should contribute to the practical implementation of the requirements of the Convention on Biological Diversity Nagoya Protocol on
Access and Benefit Sharing
20. The future GBRCN should establish mechanisms to work with policy makers to develop
and implement practical and adequate measures for legislation compliance for BRCs and
for informing BRCs of legislation impact on their activities
Policies
21. Biological Resource Centres are essential for society in enabling and promoting biotechnology, science and training. This message must be promulgated at the political level in these
economically strained times. International collaboration of BRCs is the only feasible way
to implement cost effective measures to facilitate innovation and discovery to address the
bio-economy and the global challenges to society
22. Outreach to the animal and plant domains should be established by the future GBRCN
23. A next phase for this initiative is recommended to give continuity to the process of GBRCN
consolidation and establishment
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
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Final Report on the GBRCN Demonstration Project
WORK PACKAGES
III. WORK PACKAGES
1. WORK PACKAGE 1: MANAGEMENT OF THE PROJECT, OUTREACH AND
COMMUNICATION
1.1. ORIGINAL AIMS AND OVERVIEW OF PROPOSED WORK
Besides delivering the management of the project, this work package was devoted to developing the elements for the effective cooperation in the demonstration project and those
on which a future GBRCN would be built. Among these were:
•
design a web portal for the demonstration project and produce publicity material on the
GBRCN and its outputs
•
organise regional seminars (1) South America: Brazil, (2) Europe: Portugal/Spain with
bridging to South America and Africa; (3) East Asia: China (4) East Africa: Kenya; with the
aim to (a) establish outreach to the collection community, provider / user communities,
governments and regulatory bodies (b) co-ordinate input and feedback from partners on
all work package elements concerning architecture, governance, operations and activities
of the envisaged GBRCN (c) connect to the user community to identify gaps and anticipate
needs
•
design the architecture and governance of the GBRCN including (1) a Memorandum of
Understanding to be signed by Governments and (2) a Cooperation Agreement to be signed
by cooperating entities
•
design the structure of the coordinating Secretariat, including establishment of mechanisms
to decide on host institution and host country
•
lay the basis for agreed procedural work for the day-to-day collection related practice
1.2. SUMMARY OF WORK DELIVERED
The GBRCN Demonstration Project is one of the first attempts to deal with the establishment of a research infrastructure beyond the national or regional boundaries. During the
work in the project it was established that for such an infrastructure priorities should be
set to enable meeting the global challenges. Those priorities would:
•
enhance global availability and counter loss of good data, of authentic reference organisms
and of expert knowledge
•
offer a structured environment to cope with increasingly differing legal requirements in
handling, access, use of microbial resources; but also to share burdens, establish synergies
and build trust
•
help implement the OECD Best Practice Guidelines which in turn will heighten abilities of
collections to deliver high quality scientific services
•
open better access to ex-situ material and related data through global interoperability
The direction would be towards a strong, meaningful infrastructure that would need:
10
•
to be science based, user community orientated and clearly service driven
•
sustainable partnerships between responsible bodies and implementing levels to develop
funding strategies
•
supporting policy to facilitate cooperation and overcome national borders
•
improved communication with governing bodies who set policies and research
programmes
•
stratified approaches triggering regional and national cooperation
WORK PACKAGES
Figure 1.1 The three founding pillars based on quality and capacity building accompanied by
appropriate focussed cluster activities and their management will deliver the services and resources needed by modern research.
Capacity Building is one of GBRCN’s pillars for the sustainable development of Biological
Resource Centres. Through the transfer of knowledge as well as skills and abilities,
GBRCN supports BRC candidates as well as already approved BRCs and accompanies them
through the development process (see WP2 for more details). The focus of the capacity
building is on
•
helping countries to establish BRCs,
•
enabling BRC candidates to become BRCs,
•
assisting approved BRCs to gain higher levels of compliance to the OECD Best Practice
Guidelines (BPG) and
•
supporting political and socio-economic decision making processes in the fields of BRC
related issues.
1.3. KEY OUTPUTS WITH REGARDS TO DELIVERABLES
Contributions and Funding
This project was special in that only a central coordinating secretariat received core
funding, while all the partners – including those involved in the central secretariat - contributed at their own expense. In individual cases some of them were able to secure additional national funding (see WP4 for more details). Given this background, the outputs of
the project cannot be estimated highly enough. This dedicated engagement of the participating collections shows the strong interest in such a type of mandated global collaboration of microbial service collections. All partners contributed actively and in-kind to all
aims of the project, and e.g. covered all costs for travelling to meetings while some partners additionally provided particular input by organising and financing the planned regional seminars. The Brazilian partners organised and financed a pre-project seminar in
Brazil in 2008 and the regional South-America seminar in Brazil in November 2009. The
Portuguese partner together with the Spanish partner organised and financed the regional EU-seminar in Portugal in May 2009. The Chinese partners organised and financed
the regional Asia seminar in China in 2010. An additional, auxiliary project that was
secured by the demonstration project secretariat helped to fund the regional East-African
seminar in Kenya in 2011.
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WORK PACKAGES
A very positive sign of support came from the Taiwanese government through its Ministry
of Economic Affairs who decided, besides encouraging their BCRC to participate in the
project, to financially support their participation and to contribute directly to the coordinating secretariat.
Throughout the project good coordination with on-going activities was established; in
particular using the impetus of existing voluntary scientific networks: on the regional
level (such as the annual ECCO meetings in the EU which took place during the period of
the project in 2009 in Sweden, 2010 in Turkey and 2011 in the Netherlands) as well as on
the global level with WFCC’s ICCC-12, 2010 in Brazil.
Web Portal
A comprehensive web portal has been built, which later will develop into the connecting
entity of the future envisioned information resource. It will enable future multi-layered
uses from open access of users to information and resources to internal confidential
communication between partners. It is constructed to foresee future connection with
various data base providers and will have a direct link to the biosafety / biosecurity data
base that is being set up by partners. For the time being it informs visitors about the goals
and actual activities of the Demonstration Project and the aims of the future GBRCN. In
a password secured space more detailed information on the seminars, the lectures and
discussions is accessible for partners and funders.
Seminars
To reach regional user and provider communities, as well as those governments and regulatory bodies, and to give partners the opportunity to discuss in a concise manner particular subjects a series of seminars were arranged.
The Brazilian partners organised and financed a pre-project seminar in 2008 and a regional South-America seminar in Porto de Galinhas, Brazil, in November 2009. The meeting
focussed on quality and capacity building in BRCs and implementation of the OECD Best
Practice Guidelines and was attended by an encouraging good representation of the
Brazilian government and regulatory bodies.
The Portuguese partner together with the Spanish partner organised and financed a regional EU- seminar in Guimaraes, Portugal, in May 2009. This was accompanied by a training course on microbial identification techniques. This first outreach seminar of the
GBRCN Demonstration Project provided the basis for the alignment of the various applicable ISO standards and available specific guidances. A standard (French Standard NF
S96-900, based on the OECD Best Practice Guidelines) and models for an information
system were provided.
The Chinese partners organised and financed a regional Asia seminar in Beijing in 2010
during which the quality management of microbial resources and Best Practice Guidelines
for Biological Resource Centres (BRCs) were discussed.
An auxiliary project secured by the demonstration project secretariat helped to fund the
regional East-African seminar in Nairobi, Kenia in 2011. This seminar brought together
regional scientists and Kenyan Government and regulatory body representatives, as well
as experts from around the world to discuss the requirements of modern research and
implications of legislative developments. The topics covered biodiversity, networking,
material transfer / ABS / IP issues, the CBD, how to secure sustainability and other GBRCN
topics such as quality, capacity building and personal training.
12
WORK PACKAGES
A seminar in Brussels in December 2009, organised jointly by the GBRCN Demonstration
Project Secretariat and the Brussels Bureau of the German Leibniz-Association brought
forward to EU representatives the ideas of a GBRCN and helped to put a vision for a microbial resource research infrastructure on the ESFRI roadmap.
Governance model / Architecture of the GBRCN
It has been stressed by the OECD that a strong, science based and user orientated infrastructure is necessary, that would network the BRCs and bring them together with user
communities and regulatory bodies, to appropriately underpin bio-economical developments. The building blocks for the architecture and governance of the future GBRCN
include a non-legally binding Memorandum of Understanding (following the model of
the Global Biodiversity Information Facility whose experience over many years show the
effectiveness and efficiency of such a framework). In this MoU it is laid down what the
purposes are of this initiative and how to reach them, what the responsibilities are and
where they lie, start and termination of participation, financial contributions to the longterm functioning of the initiative, and further items. This document is intended to be
signed by participating / funding countries or economies who would delegate a representative to the GBRCN Governing Board. Countries/economies might decide to nominate a
national entity for cooperating in the practical goals of the network. A GBRCN would come
into force when enough signatures have been received to represent a minimum financial support to keep a meaningful coordinating secretariat alive, which would, following
the suggested financial framework, require 5 to 8 countries or economies. The Governing
Board will guide the GBRCN Secretariat in its actions and development. In this it will be
supported by an Advisory Board.
A central secretariat will co-ordinate activities and work on behalf of the cooperating
entities. This body will be hosted by an institution in one of the participating countries/
economies. Rules have been laid down for the host/host country selection process, selection of personnel and functions of the secretariat and their respective mutual rights and
duties. The secretariat’s responsibilities for the day-to-day coordination of the network or
specific areas, initiation of co-operations and projects for, with and between cooperating
entities, outreach and linkages have been described.
For the cooperating entities, a Cooperation Agreement (CoopAg) has been developed for
BRCs in which, among other items, the various types of cooperation and levels of Best
Practice compliance are described. Cooperating entities would bind themselves to the
spirit of this agreement by their signature. The CoopAg would need amendment when the
entity is a network of BRCs depending on the degree to which it implements the GBRCN
operation principles.
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Final Report on the GBRCN Demonstration Project
WORK PACKAGES
Figure 1.2 GBRCN Architecture
Direct collaboration should be through entities (individual BRCs and BRC networks on
the national and regional levels) that are mandated towards the OECD BRC Best Practice
Guidelines (OECD BPG) and other rules as laid down by the GBRCN to guarantee delivery
of high quality resources and services. At the beginning of the functioning of GBRCN, it
will be mainly the individual BRCs who directly cooperate through GBRCN. Over time, as
the structures develop, and more and more BRCs are established or transformed from
classical culture collections, these should be assembled in national BRC networks and
their inputs coordinated through these networks. Regional BRC networks should complement this coordination to unite the voices of BRCs to enable a stronger political influence.
This would make it possible for the mandate to ascertain adherence to OECD BPG to be
handed down from the GBRCN level to the regional or national level and would help to
keep a lean central administration.
This stratified approach should be constructed in an effective way to avoid unnecessary
duplication of efforts. Not everything needs to be established everywhere.
Close cooperation with voluntary national, regional and global federations of collections
should be firmly built up to enable regular and open discussions and flow of information
for mutual benefits.
To streamline collaboration and to optimise development, a twinning system between
BRC >and< classical or research collection, national BRC Network >and< national federation of collections, regional BRC Network >and< regional federation of collections should
be considered.
Outreach to other entities such as regulatory bodies, user groups and scientific societies
and federations, each on the national, regional and global level needs to be established
and mechanisms to cooperate found.
Generally many of the partners regretted, that the project did not provide financial support
for the partners and that matching national funding was difficult to find. Some partners
stated that their input to the project was less than they had hoped to provide and that
therefore some of the ambitious aims of the project could not be fully reached.
14
WORK PACKAGES
Figure 1.3. Suggested Cooperation Structure for the long-term GBRCN
However, some partners indicated that the fact that they were partners to the GBRCN
Demonstration Project triggered their governing bodies’ interest and willingness to
provide national matching funding at least on the basis of short-term projects. Here, the
Brazilian partners had been particularly successful in securing additional funding from
four different sources (see more in chapter on Work Package 4) and harnessing a longterm interest of their government in setting up and quality management of BRCs.
Another generally raised point of disappointment was that it had been considered extremely difficult for many of the partners to reach government representatives in the respective area. This might have been due to the overall critical financial situation of many
countries. However again, other partners had been very successful in this respect.
Most partners stated that their expectations had been met by the project and that they
have taken great advantages from it. Some partners stated that their collection already
had gained in quality and credibility through participation in this project, which they,
e.g., can see from their customer feed-back. The Spanish partner stated that, even if direct
contact to their ministry proved to be difficult, their own active involvement in the GBRCN
Demonstration Project might have had a positive influence on the funding coming from
their Ministry and their hosting university for their new, larger facilities and new equipment, as well as on their own general higher recognition.
All partners estimate highly the value of establishing a mandated global platform for
coordinated collaboration of holders of living biological resources and their stakeholders. However, some of the partners raise doubts as to whether their governments would
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
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WORK PACKAGES
consider signing the GBRCN MoU in the near future, or that appropriate long-term funding
could be easily secured.
VTT: ‘The message about the importance of MRCs for society in enabling and promoting biotechnology, science and training is very hard to get through to political contacts
in economically strained times. However, international collaboration of MRCs is the only
feasible way to influence the policy makers.’
CRIA: ‘Historically, the establishment and operation of microbial culture collections in
Brazil is derived from the need to store the products of research projects at institutional collections, and not directly associated with the need to implement a permanent
infrastructure to supply biological material and specialised services to the community.
Therefore it is still difficult to secure long term funding to consolidate a public service
infrastructure to meet the users’ needs.’
CECT: ‘Although we were not able to obtain any supporting letter from our government
(the respective ministry is MICINN) for GBRCN, we could finally convince them of the
importance of supporting the MIRRI proposal with a letter. But, after the elections, all the
political structures have been reorganised, the MICINN has disappeared and the possibilities to obtain any support for anything related to GBRCN are nil.’
List of key outputs of GBRCN and their rating by partners
16
WORK PACKAGES
1.4. CONCLUSIONS
Overall, the WP aims have been met and
the deliverables been judged useful for the
establishment of the GBRCN.
The demonstration project has already provided
evidence for the benefits of collaborative efforts,
… There is a demonstrated need for a small
Secretariat with permanent dedicated staffing
to work on behalf of BRCs worldwide.
The only drawback from the original aims
is that no direct government commitA. Kaukovirta-Norja, Vice President,
ments could be firmly secured to support
Technical Research Centre Finland
a GBRCN in future, although a number of
very positive estimations from this side
were received. One reason for this may
have been that it would be much easier for politicians to support at the national level
rather than regionally or globally. Transferring funds across borders seems to be very
difficult. The present economically strained situation in many countries around the
world was another main reason for this lack of responsiveness. However, at the recent
International Conference on Research Infrastructures, 21 – 23 March 2012 in Copenhagen,
the need for expanding infrastructures to reach the global level was clearly stated. This
might trigger a renewed interest in expanding the established model into a fully performing infrastructure.
1.5. RECOMMENDATIONS FOR THE SUBJECT OF THE WP WITH REGARDS TO
A FUTURE GBRCN
1.5.1. The suggested structure of global interaction of the GBRCN should take into consideration
•
a stratified approach that links the global, regional and national levels
•
to link mandated BRCs and their networks with non-mandated, voluntary regulated
collections and their networks
•
to connect to governing and regulatory bodies
1.5.2. To render the GBRCN viable and sustainable, structured, matching funding should
be sought (see WP4 for more details)
•
from various types of sources
•
from the global, regional or national level; and specific budgets should be assigned to:
— the collaborating entities
— the network functioning
— the coordinating secretariat
1.5.3. The goals and the collaboration in GBRCN should be firmly based on quality of resources, data and services and the related capacity building
1.5.4. Funding agencies should be advised that research infrastructures should not have
to compete for funding with the research they are meant to serve; both activities should
be better linked to each other for mutual benefit
1.5.5. The various regional and national initiatives should be effectively reconciled so
that progress is not hampered and unnecessary duplication avoided
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WORK PACKAGES
1.6. LIST OF ANNEXES
•
Memorandum of Understanding for Governments ( Containing Annex I Financial
Contributions for voting Participants, Annex II GBRCN Cooperation Agreement, Annex III
Request for Proposals to Host the Secretariat): Document GP-PM-0008 GBRCN MoU
(see electronic and printed Annex)
•
Document on GBRCN Architecture: Document GP-PM-0013 GBRCN Architecture
(see electronic and printed Annex)
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WORK PACKAGES
2. WORK PACKAGE 2: BRC QUALITY MANAGEMENT AND IMPLEMENTING
COMMON STANDARDS AND PROTOCOLS
2.1. ORIGINAL AIMS AND OVERVIEW OF PROPOSED WORK
The Best Practice Guidelines for BRCs were intended by the OECD to serve as a target for
the quality management of collections. But rather than seeking full compliance, the set
of guidelines is originally meant to provide guidance for those collections that seek to
improve quality of the BRC in total. Hence the OECD Best Practice Guidelines for BRCs
(OECD, 2007) include general guidelines for the acquisition, maintenance, provision of
biological material and the management of BRCs as well as specific best practices for
those BRCs that hold and supply biological material within specific domains. In addition,
guidelines are available for biosecurity and third party quality audits.
The GBRCN Demonstration Project designed WP 2 to pick up activities of different initiatives, projects and federations (CABRI, WFCC, ECCO, GBRCN and EMbaRC) and to offer a
way forward to implement the best practice guidelines alongside applicable international
standards and official certification and/or accreditation mechanisms (e.g. ISO 9001 and
ISO 17025). Knowing full well that there will not be one single implementation routine, the
Demonstration Project targeted the delivery of appropriate strategies for the implementation of OECD Best Practice Guidelines for Biological Resource Centres. Supplementary to
this goal, the project should demonstrate a model for compliance proof by independent
third parties based on globally accepted certification and accreditation methods.
Work package 2 provides the basis for achieving the core goal of the GBRCN which is
to give access to validated biological materials and their associated services and information, to validate microbial resource centres and to harmonise common standards for
authentic and high quality biological material.
The overall goals of the work package were:
•
to assess the current status of implementation of best practice and to offer a stepwise
implementation model of OECD best practice guidelines
•
to implement mechanisms for third party assessment to OECD best practice guidelines
•
to develop assessment tools for the future GBRCN
•
to ensure the networking activities have a common platform and that all partner BRCs
operate high standards
•
to develop tools and mechanisms for synergistic effects and know-how sharing in quality
matters
•
to provide outreach beyond the demonstration project
2.2. SUMMARY OF WORK DELIVERED
To reach the goals of the work package, deliverables and milestones were defined expressing the need for a common understanding of quality management and transparent, as
well as harmonised, operating procedures based on the OECD best practice guidelines.
Thus establishing the guidelines in partner collections (D2), drafting guidance documents for the audit process (D5) and designing a mechanism for third party assessment
of BRCs (D3) were the most important deliverables to serve the requirement triangle
(Figure 2.1) in the ambitious, bio-economic environment with high quality and performance expectations.
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WORK PACKAGES
Figure 2.1 The requirement triangle of BRCs
Closing the gap between the different expectations is one of the main requisites for a
GBRCN. Thus, developing and implementing standard operation procedures (D3), attempting to harmonise accession and authentication procedures (D11e) and producing tools
like e- learning to assist in building capacity (D10) were accompanying deliverables within
work package 2.
Figure 2.2 The GBRCN as a vital link in microbial diversity use in research and development
The importance of establishing a GBRCN as a vital link serving the spectrum of demands
in the microbial resource supply chain was very well illustrated in the three years of
the demonstration project. Relating to common BRC quality management, the successful
realisation of the deliverables is well emphasised by the participating partners of the
project. Many of whom pointed out that analysing and implementing the OECD best
practice guidelines as an outcome of the project have had a major influence in the operations of the collection:
BCRJ: The main contributions are related to the implementation of the quality management system based on the ISO IEC 17025 regulation and the guidelines for best practice
for the BRCs of the OECD. Secondary concerns are biosafety and biosecurity, as well as
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WORK PACKAGES
management of the collection through software with barcodes which controls all administration of collections and laboratorial activities.
CABI: The main area where the outputs of the GBRCN project have influenced CABI
operations is in the further development of our quality management systems. The selfassessment process instigated by the GBRCN project has thus helped CABI implement a
programme for the development of excellence in its operations.
IST: The analysis of the OECD Best Practice Guidance, information on legislation and the
code of conduct on bioescurity have influenced the operations of my collection, and in my
opinion this is true for all.
CRIA: Opportunities derived from the implementation of the GRBCN demonstration project
were critical to the development of the Brazilian capacity building program focused on
the improvement of quality management.
VTT: The outcomes with most influence for the VTT Culture Collection are the evaluation
to the OECD Best Practice Guidance.
Furthermore, developing a Third Party auditing procedure as a deliverable within work
package 2 was acknowledged by the project partners:
CRBIP: The best practice guidelines have to be ubiquitous and needs to be audited by an
official national company of certification.
BCRC: Implementation of best practice guideline is difficult, partly in uncertainty about
interpreting the guideline, and partly in meeting the high standards.
Thus the perspective given by the demonstration project with regards to a stepwise
compliance procedure embedded in an independent certification model, should serve
well as a future model for compliance management and Third Party Audits. The concept
being developed by the demonstration project is based on the excellence model defined
by EFQM and resolves the restrictive regime of standards by offering a stepwise development in accordance to the available resources and demands.
Figure 2.3 The development of excellence model for BRCs
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WORK PACKAGES
2.3. KEY OUTPUTS WITH REGARD TO DELIVERABLES
Highlighting the most meaningful outputs of work package 2, the results of the self-assessment, in which eleven of the sixteen project partners participated, provided far-reaching
input for future activities regarding quality management system for BRCs. Although the
overall compliance indicates that 60 % of all project partners are operating according to
the OECD best practice guidelines (Figure 2.4), a non-compliance of 40% is a strong indicator that assistance is needed in reaching the requirements. This picture is confirmed by
looking at a more detailed level into the individual partner and domain specific results.
Figure 2.4 Self-assessment results on total compliance
Considering that biosecurity is one of the major aspects of a BRC’s social and political
responsibility, the response that a majority of all partners are not able to implement the
OECD best practice guidelines is an alarming signal (Figure 2.5). The reasons for this inability to implement were various including lack of funds, low staff numbers misinterpretation of the needs of the guidance for example overestimating the level of biosecurity risk
assessment where only published and available criteria are used.
Figure 2.5 Self-assessment results on biosecurity
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Consequently, the capacity building model (Figure 2.6) suggested by the Demonstration
Project becomes more important in consideration of the assistance which a GBRCN will
be able to give BRCs at the different levels of their development.
Figure 2.6 The GBRCN capacity building model
The process of transition of a culture collection to a BRC has several steps that can be
facilitated by a common capacity building programme. A threshold level of best practice
is required to become a BRC and when a culture collection has developed good practices
it can use the GBRCN self-assessment tool to receive guidance to reach this threshold
level. The results of the assessment will identify gaps in implementation of the OECD
best practice guidance. Based on this the collection can define an action plan that moves
it through the different levels of compliance. Candidate BRC’s development can be accelerated along the track towards excellence by providing to them SOPs, example mechanisms and knowledge to bridge the gaps. The collection’s individual action plan can be
prioritised to suit the importance of the best practice element (see figure 2.3) and its relevance to the collection goals and its users’ needs. Such factors increase the chances of a
successful shift of a collection to become a modern BRC. The project showed that the so
called “ABC” of BRCs is mainly defined by the following indicators:
•
Authentication procedures implemented
•
Best practice in preservation and management
•
Confirmed and validated information
As capacity building requires different modules, the demonstration project looked for the
most helpful instruments, such as those shown in figure 2.7. A very suitable instrument
is e-learning, which is especially useful considering the problem of funding, time and
resources available. The Managing Microbes e-learning tool has been designed by CABI
and will be made available for use by GBRCN capacity building programmes. Based upon
the usefulness of this a special module to assess compliance to OECD best practice should
be considered by a follow-up project.
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Figure 2.7 Useful tools for the capacity building for culture collections
One of the strengths of the GBRCN Demonstration Project was the linkage to other
underpinning projects like EMbaRC. This linkage clearly demonstrated the importance
of network structures through the synergies of which e.g. a much broader spectrum of
methods can be provided, which definitely gains in importance by inclusiveness rather
than by exclusiveness. The deliverable of providing Standard Operating Procedures (SOPs)
relied on the synergy with work package NA1 of the EMbaRC project in which drafting of
a quality manual and compiling SOPs was delivered by the project partners. Some of the
GBRCN partners have participated as EMbaRC partners in the inter-laboratory testing,
through experience exchange on the accession and authentication procedures and by the
provision of SOPs for accession and authentication procedures.
2.4. CONCLUSIONS
The three years course of the project has demonstrated that this work package is at the
very core of the operational work of each collection and BRC. All main activities: to create
repositories for biological material, to make this material accessible and to provide users
with validated data need to be anchored in a strong quality management system which
is defined by global demands. The work package outputs show a significant need for a
system that facilitates:
•
incorporation of the different remits of the variety of BRCs that originate from university
based laboratories or independent, company structured organizations and variations in
between with their different funding structures
•
more detailed and sustainable assistance in interpretation of the OECD best practice
guidelines
•
setting up universally valid master procedures and creating a library of Standard Operating
Procedures
•
defining codices and operational agreements
•
rolling out the certification procedure based on the excellence model
•
establishing a capacity building center to support the excellence model for developing
BRCs
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This was reflected by the partner feed-back provided to GBRCN demonstration project
secretariat:
CLIOC: The major difficulty concerning the implementation of OECD guidelines is related
to the existing structure for biological collections at Fiocruz. CLIOC is part of a research
laboratory.
CECT: The need to reach harmonized procedures for accession and supply, respecting the
CBD but also taking into account the special characteristics of the microorganisms is a
main challenge, especially after the Nagoya Protocol. This should be one of the outcomes
of the GBRCN in the new period.
BCRC: Difficulties are standard operation procedures for biosecurity management in
microbial collections, database for assessing biosafety and biosecurity.
CBS: Difficult is the implementation of some elements of the OECD guidelines (full implementation not possible at the moment), in particular biosecurity risk assessment.
2.5. RECOMMENDATIONS FOR THE SUBJECT OF THE WP WITH REGARDS TO
A FUTURE GBRCN
2.5.1. Establish a work group, project or cluster to facilitate culture collection transition
to become BRCs and their adoption of the excellence model
2.5.2. Establish capacity building tools to facilitate the establishment and operation of
quality management and the implementation of the OECD best practice guidelines
2.5.3. Establish capacity building programmes to address the scientific and technical
needs, including laboratory work, systematic / taxonomic techniques, etc as a necessary
basis for overall quality
2.6. LIST OF ANNEXES
•
Self Assessment GBRCN all General (see electronic Annex)
•
Self Assessment GBRCN all biosecurity (see electronic Annex)
•
Self Assessment GBRCN all Micro (see electronic Annex)
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3. WORK PACKAGE 3: COMMON APPROACHES EXPLORED TO IMPLEMENT
AGREED PRINCIPLES ON BIOSAFETY, BIOSECURITY, RISK ASSESSMENT,
OWNERSHIP AND MANAGEMENT OF IP ENFORCED BY EXISTING NATIONAL,
REGIONAL AND GLOBAL LEGISLATION
3.1. ORIGINAL AIMS AND OVERVIEW OF PROPOSED WORK
The objective of this work package was to design and implement common approaches to
compliance with legislation, regulations and international conventions to ease the load
on the individual BRCs and reduce the confusion of the user community through the
plethora of different procedures. To lay down the foundation for this, firstly a comprehensive coverage of legislative requirements for at least the partner countries on legislation
that impact upon BRC activities was necessary. Secondly, a few specific areas were to be
more fully addressed. The work covered:
•
compilation of legislative and information on existing initiatives for delivery online via the
web
•
discussions and agreements on harmonized approaches to legislative background for work
in a BRC; which embraces accessioning and delivery, access to biological material; work
with, authentication, identification, storage
•
development of approaches to the implementation of the OECD Best Practice Guidelines
on Biosecurity in partner collections; define the extent to which they are already followed,
define obstacles and how to overcome these; a subtask was to keep close links with e.g.
WHO, EBSA and CEN
3.2. SUMMARY OF WORK DELIVERED
There are numerous areas where policy, regulations or legislation impact on the operations of BRCs with Governments, policy makers, communities and practitioners developing approaches for compliance.1 This work package collated output from existing
activities and placed key documents and links on the GBRCN Demonstration Project web
site. Liaison with experts and stakeholder groups, particularly in aspects of implementing access and benefit sharing in respect to the Convention on Biological Diversity and
its Nagoya protocol and implementation of best practices in biosecurity helped in the
development of appropriate model procedures for BRCs. The goal was to demonstrate
that coordinated effort across networks can develop tangible outputs for the day to day
practice of BRCs. Additionally an assessment of impact of the implementation of the CEN
CWA Biorisk standard was drafted. A key output in this regard was the design and high
level endorsement of the Biosecurity Code of Conduct for BRCs (CoC).
3.3. KEY OUTPUTS WITH REGARD TO DELIVERABLES
Background to develop common approaches to legislation compliance (Deliverable 6) was
provided by placing legislation information on the GBRCN Demonstration Project web site
1
Impacting legal background:
• The Convention on Biological Diversity • Cartagena Protocol to the Convention on Biological Diversity • Nagoya
Protocol on Access and Benefit Sharing • Convention on International Trade in Endangered Species (CITES) • Biological,
Chemical and Toxin Weapons Convention (BTWC) • FAO International Treaty on Plant Genetic Resources for Food
and Agriculture • International Plant Protection Treaty (IPPT) • Trade Related Aspects of Intellectual Property Rights
(TRIPS) Agreement and other Agreements within the World Trade Organisation (WTO) • Budapest Treaty on the
International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure • A multitude of
import, export, transport and quarantine regulations
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WORK PACKAGES
(www.gbrcn.org). The prime activity focussed on drafting the CoC in collaboration with
the EMbaRC project. A small discussion group with representatives from key European
partners met to develop a harmonised approach. Project position papers were drafted
and circulated for comment from partners in the 3rd Intermediary report to BMBF (Annex
15). The CoC was presented to the OECD and most significantly, to the Biological and
Toxic Weapons Convention (BTWC) 7th Review Conference where it was received well as
a mechanism for awareness raising and implementation of best practice. In the future, a
guiding paper needs to be developed on how BRCs should and can implement the requirements of the Code of Conduct.
The goal of developing practices of international applicability for all BRCs has laid down
an important cornerstone in the creation of a legal operational framework for the operation of BRCs and the future GBRCN.
The implementation of principles for approaches to risk assessment (Deliverable 7) was
addressed to rather focus on the less well covered biosecurity risk assessment than to
address all elements of risk assessment of the BRC work. A guidance document on risk
assessment is incorporated in the paper on practical implementation of the CoC.
As a model system related to biosafety and biosecurity a gap analysis between the
European CWA biorisk standard, OECD Best Practice and relevant European legislation
was carried out. A review of the CWA biorisk standard and a support paper were designed
to enable BRCs to put in place practices that respond to risks from organisms handled and
to comply with national health and safety legislation (where applicable).
The Code of Conduct on Biosecurity for Biological Resource Centres (CoC) developed jointly
with the EU funded project EMbaRC and presented to the BTWC 7th Review Conference
is given below.
Access to the biodiversity relevant legislation of all countries is not always easy, it is
in different languages, often not comparable in scope, content and enforcement mechanisms and sometimes it is not available. Having partners from different countries helps
facilitate access. A large effort outside the scope of the demonstration project is needed
to deliver a comprehensive information resource for BRCs and their users. Where legislation does not exist, network membership criteria will have to lay down the principles that
need to be implemented in such cases. The Biosecurity Code of Conduct for BRCs offers a
model for setting binding operational criteria which, although not legally binding, must
be implemented if an entity wishes to participate in the network. Risk assessment continues to present problems to culture collections. However, it is clear that risk assessment
is based on what is known and does not demand from BRCs in depth research to be able to
carry out a suitable risk assessment. A BRC needs to be aware of published and generally
available information on the biological material, adapt their own procedures accordingly
and make this information available to their customers. There are still several areas of
legislative impacting on BRCs that need to be addressed and although raising awareness
of the legislation is a first step, often interpretation and community applicability needs
assessment. How e.g. access and benefit sharing is to be addressed will be dictated by how
countries implement the requirements of the Nagoya Protocol. BRCs need to input to the
process and influence the options how Governments will implement this protocol.
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The Code of Conduct on Biosecurity for BRCs has been published at several levels.
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The poster describing the CoC was presented at the 7th Review Conference of
the BTWC.
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WORK PACKAGES
The importance of the aspects of work undertaken and the output generated was demonstrated by the comments and reports of the partners.
BCRC/FIRDI‘s main topic of input to the GBRCN Demonstration Project was in the area
of biosecurity, specifically milestone MS3.5 Code of conduct on biosecurity. BCRC/FIRDI
set themselves the targets to establish mechanisms to facilitate material transfer across
borders and to share experiences from other collections on improving management such
as managing biosecurity and implementing best practice guidelines and were pleased
with the outcome.
The CECT has contributed to the development of harmonised MTAs for accession and
supply of strains in accordance to the CBD (particularly in relationship with Access and
Benefit Sharing). They indicated that biosecurity/biosafety was a difficult point for BRCs.
They commented that regulations are very different at national level, and in some countries there is no regulation on biosecurity applicable to BRCs.
CABI points out that the GBRCN Demonstration Project should be proud of its delivery
of networking tools, policies and strategies which have been recognized at the highest
levels. In particular the ESFRI national delegates and the European Commission evaluated
the work of GBRCN quite highly in the process of placing MIRRI on the ESFRI roadmap.
A second output, the CoC (produced in collaboration with the European project EMbaRC)
was recognized as a useful tool at the Biological and Toxic Weapons Convention’s seventh
review conference.
VTT commented that many of the project outputs have been very relevant and important. Sometimes it has been challenging to follow all the sent information in addition to
all other collection work and other urgent projects. Therefore it would be very useful to
find all the information easily on the web site.
The Brazilian BRC Network made additional comments on national legislation on
Biosecurity. At the moment in Brazil there is no legislation for biosecurity. This necessity and consequently the need for a governmental department to address the issue have
been raised by the OECD Best Practice Guidelines for Biological Resource Centres. This
has driven partners to contact different sectors of the government that could be involved
with this matter. As a result, contact has been made with the Defence Ministry (MD) and
the Science, Technology and Innovation Ministry (MCTI) in order to start this process;
already some meetings have been planned.
3.4. CONCLUSIONS
The envisaged outputs were reduced to enable key aspects to be addressed in more depth.
Biosafety, in contrast to biosecurity, is an area that is usually covered, though to different
extents by different countries. Additionally, national legislation is in place in most countries that covers the broader elements of health and safety and therefore these were not
considered a priority for the GBRCN Demonstration Project to tackle.
Of greater relevance is the Biosecurity issue and specifically the Biosecurity risk assessment. As an example of available instruments, the CWA Biorisk standard established in
Europe was examined. This addressed both biosafety and biosecurity risk assessment.
BRCs in Europe could take the option to become certified to the Biorisk standard but
further analysis from a global perspective demonstrated that compliance with national
legislation and adhering to OECD Best Practice Guidelines for BRCs addressed most issues.
For countries without comprehensive legislation, the combination of the OECD guidance
and WHO documentation on the topic would provide better options.
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The key problem identified in the partner assessment on the implementation of OECD
Best practice in WP2 was assessment of risk in terms of biosecurity. The OECD guidance
on this aspect was demanding and seen to be beyond the ability of normal culture collections. However, it is clear that risk assessment is based on what is known and does
not demand from the BRC actual in depth research to be able to carry out a suitable risk
assessment. A BRC needs to be aware of published and generally available information
on the biological material, adapt their own procedures accordingly and make this information available to their customers. To aid in the general implementation of biosecurity
practices and raise awareness, the Code of Conduct was developed, tested and verified as
a key tool in control of dual use; it received BTWC Review Conference endorsement.
In terms of ownership and management of IP the
Budapest Treaty controls management of microorganisms as part of patent procedures and the OECD
Best Practice and the World Intellectual Property
Organization (WIPO) cover these aspects sufficiently. In terms of ownership in respect to the CBD,
this too is well defined but negotiations continue
with relevant CBD stakeholder groups and national
authorities regarding the development of national
or regional mechanisms to implement the Nagoya
Protocol (NP; see http://www.cbd.int/abs/text/).
The NP lays down requirements concerning Prior
Informed Consent (PIC) and Mutually Agreed Terms
(MAT) where access to a country’s biodiversity is
sought. The principal requirement is that “benefits
arising from the utilization of genetic resources as
well as subsequent applications and commercialization shall be shared in a fair and equitable way with
the Party providing such resources that is the country of origin of such resources or a
Party that has acquired the genetic resources in accordance with the Convention” (Article
5). The implementation of the protocol demands the development of national legislation
and, if not approached appropriately may well impede access and exchange of materials
and information. In this context the collection community will have to work towards
a mutually beneficial multilateral operational framework to facilitate and not inhibit
science and the discovery process.
Considering the elements discussed under the feasibility of deliverables and milestones
above (3.3) the major outputs have been reached. An information resource has been made
publicly available and the key, formerly neglected, area of implementing biosecurity best
practice specifically for BRCs has been adequately addressed and endorsed at the highest
level. Work is still on-going to produce a database tool to help with access to legislation and risk assessment and the cooperation with the EMbaRC consortium is looking to
produce a document on the practicalities of implementing the Biosecurity code of conduct
for BRCs.
The information review and delivery resulting in documents on the GBRCN Demonstration
Project web site highlights requirements that BRCs must implement in order to comply
with legislation. This helps prepare candidate participants in the GBRCN to implement
the key principles of being a BRC i.e. compliance with legislation. The comprehensive
Biosecurity Code of Conduct for BRCs will form a key element in the legislative compliant
operational framework for the GBRCN.
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3.5. RECOMMENDATIONS FOR THE SUBJECT OF THE WP WITH REGARDS TO
A FUTURE GBRCN
3.5.1. The Biosecurity Code of Conduct for BRCs is an accompaniment to the GBRCN Cooperation Agreement and is open to be adopted by all culture collection/BRC organisations, networks or research infrastructures
3.5.2. The future GBRCN should develop guidance on how to implement the requirements of the Code of Conduct
3.5.3. The GBRCN as a whole and BRCs specifically should contribute to the practical implementation of the requirements of the Convention on Biological Diversity Nagoya Protocol on Access and Benefit Sharing
3.5.4. The future GBRCN should establish mechanisms to work with policy makers to
develop and implement harmonised practical and adequate measures for legislation
compliance for BRCs and for informing BRCs of legislation impacting on their activities
3.6. LIST OF ANNEXES
•
Biosecurity Code of Conduct for BRCs (see electronic Annex)
•
Analysis of CWA Biorisk Standard Document GP-WP-0007a (see electronic Annex)
•
Global Biological Resource Centre Network Statement to the BTWC Seventh Review
Conference (see electronic and printed Annex)
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4. WORK PACKAGE 4: THE BRC AND THE NETWORK LONG-TERM
SUSTAINABILITY
4.1. ORIGINAL AIMS AND OVERVIEW OF PROPOSED WORK
The overall objective of this work package was to develop options for long-term sustainability of the network and provide outline model BRC and GBRCN business plans that may
contribute to their long-term sustainability. The OECD BRC Task Force report on financial aspects of BRCs and BRC networks was used as a basis to start these activities. The
possibilities for support from Governments, the private sector, BRCs and from products
and services would be explored along with the financial models available for the sustainability of BRCs developing a generic business plan that might be used by BRCs today. The
work addressed:
•
Prepare a short bullet point document on the function and operation of the GBRCN and
present possible funding mechanisms
•
Develop recommendations and contact policy makers and stakeholders to explore their
willingness to support these and produce financial strategies and business plans
•
Review and evaluation of funding situations in candidate collections
•
Visit candidate collections and with them explore how they may take advantage of such
strategies and plans and through consultation design appropriate mechanisms for each
4.2. SUMMARY OF WORK DELIVERED
The model Business plans were designed to flexibly meet country and partner collection needs. These covered Product/Service description, Unique Selling Points, The Market,
Competition, Opportunity / Risk, Business Strategy, Strengths, Weaknesses, Opportunities
and Threats and Financial/Cash flow Projections. They provide a robust and evidence
based plan to convince both BRCs to join and Governments or other sponsors to fund the
development and delivery of a GBRCN. The generic BRC business plan will be a tool to help
the individual members of the GBRCN to become sustainable through improved revenues
and usage; common lines of revenue generation were summarised (see Fig 4.1). It indicates the potential revenue generating options a BRC might have:
34
•
Government support
•
Private industrial support
•
Private industrial support for internal restricted BRC activities
•
Public and private foundation support
•
Public fundraising
•
Sale of biological resources and technical materials
•
Provision of specialist services and technical consulting expertise
•
Research income (grants and contracts)
•
Fees for repository service (safe deposits and patent strain maintenance)
•
Provision of technical courses
•
Exploitation of and adding value to genetic resources
WORK PACKAGES
Figure 4.1 Costs and funding mechanisms for network and cooperating members
The OECD BRC Task Force report on financial support for BRCs and BRC networks was
used as a basis to develop the business plan for the operation of the GBRCN. Similarly the
financial models available for the sustainability of BRCs presented by the OECD BRC Task
force and those in place at partner institutions were examined and a generic business
plan provided.
4.3. KEY OUTPUTS WITH REGARD TO DELIVERABLES
The model business plans were prepared for the GBRCN network and BRCs in general as
models for sustainability (Deliverable 15); these model plans are presented in Document
GP-WP-0068 GBRCN Draft Business Plan. The document GP-WP-0008a - BRC funding
models provided an initial internal report on approaches for the financial sustainability of BRCs and networks of BRCs in both developed and developing nations. This overview provided information and analysis to deliver the Secretariat paper on sustainability
which has been incorporated into the GBRCN Architecture document GP-WP-0013 and
the GBRCN MoU GP-WP-0008. The latter provide the key instruments for establishment of
the GBRCN. The delivery of general recommendations to Governments on the future establishment and funding of GBRCN were published in the GBRCN brochure (1000 copies).
Table 4.1 Elements of Government participation in the GBRCN outlines some of the options
on how Governments and BRCs might balance their financial support for the BRC, the
network, the Secretariat and overall activities.
Tasks 4.3 and 4.4 were modified to examine costs and benefits and the effort needed to
implement best practice rather than addressing all aspects of the financial models. This
was carried out as part of work package 2 which addressed evaluations of partners, candidate BRCs and collections wishing to operate to agreed standards (Milestones 4.5 and 4.6).
This enabled the identification of capacity building elements for the partner collections
(Milestone 4.7) (see chapter WP2).
The partners raised various issues in their overall response to the demonstration project,
to the efforts of this work package particularly, their ability to participate in this effort
and the impact of its output.
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Funding element and
action
Option 1
Option 2
Option 3
+
+
+
+
+
+
+
+
Option 4
Provide seed money to the
central secretariat for its
maintenance and to support
+
specified pieces of work
Nominate national
entity(ies) for cooperation in
GBRCN
Provide funding for this
entity to cooperate in GBRCN
Provide additional funding
+
for national developments
(+)
of BRCs
Implications
Governments
Governments
Governments
Governments
finance Network
finance Network
invest only in
finance only
activities, their
activities and
their BRC
Network
BRC’s participa-
their BRC’s
tion and deve-
participation
activities
lopment of other
entities
Table 4.1 Elements of Government participation in the GBRCN
BCCM commented that the most important output of this project should have been the
recommendations to Governments on future establishment and funding of GBRCN.
CABI remarked that a key output of the GBRCN project for future sustainability was the
collaboration with other European consortia (EMbaRC and ECCO) to place the Microbial
Resources Research Infrastructure (MIRRI) onto the European Strategy Forum (ESFRI)
road map. This will take up a large number of the GBRCN outputs and provide the regional input to the future global level.
The CECT sustainability has been improved through the Spanish Ministry of Science and
Innovation (MICINN) and the University of Valencia providing funding for the location
of the CECT in a new facility. CECT reported the need to look for additional sources of
funding related to the possible commercial uses of the strains, and that they had respective discussions with their Bureau for Research Results Transfer at the University. This is
still a pending matter, and only very few agreements have been reached until now.
VTT has gained considerable amounts of useful knowledge and experience through the
GBRCN Demonstration Project and established important contacts. International cooperation is a prerequisite in securing sustainable funding for BRC’s. Participation in the
European MIRRI initiative as associate partner is one way to advance sustainable funding
for MRC’s.
CRIA pointed out that is still difficult to secure long funding to consolidate a public service
infrastructure to meet the users need. The participation in the GBRCN project and the
resultant institutional arrangements are bringing new possibilities to secure the funds to
implement a large scale/long term program to consolidate the Brazilian BRC Network.
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The conclusion from CBMAI’s viewpoint was that the project was successful and allowed
the improvement of CBMAI’s operation and management. Additionally, their participation resulted in:
•
financial support from National Agencies, Government and companies;
•
the increment and expansion of CBMAI staff;
•
the beginning of an important link among Brazilian Collections and the Government for
the establishment of BBRCN – Brazilian BRC Network.
4.4. CONCLUSIONS
During the project life there were a number of lessons learned. To get input from partners
they require funding to cover their participation. In the context of this GBRCN demonstration project individual partners needed to secure local funds. Where this was the case,
for example in Brazil, contributions and local developments and implementation were
possible. Although recommendations were prepared for establishment and publicised in
the GBRCN brochure a clearer action plan to engage Governments was needed. Again
the fact that partners were not funded to participate, meant that most did not have the
resources and contacts at the political level to deliver these recommendations and establish collaborations. Where efforts were successful in contacting Governments by BRCs it
was evident that participation at a global level to facilitate operations, broaden and share
expertise, data and materials played a key role. International activities can be used to
leverage local funding. Utilising existing funding mechanisms has to be the main route
to sustainability as the creation of new systems is rather difficult given that available
funding is diminishing. To support national BRCs specific plans directed towards local and
BRC needs are required. There is not on single business plan that can meet all needs.
To secure the long-term sustainability of the GBRCN it seemed appropriate for the demonstration project to consider a form similar to that of GBIF and its financial structures. Once
this decision had been made, the MoU GBRCN document GP-WP-0008 was designed that
described the structure, provided the key tool for establishment and presented the financial model of national fees to support the running of the Secretariat and its work. Having
agreed this sustainable way forward for the Secretariat, funding models for BRCs were
examined (GBRCN document GP-WP-0008a BRC funding models). From this, generic business plans were designed for use both by the project partners and by culture collections
in general.
For the individual BRCs the national operational environments and possible funding
mechanisms are quite different. Although some partners reported that they gained a
higher profile through the project which facilitated some additional financial support
little could be done centrally other than provide a generic support in rationale and possibilities for funding models. With regard to a sustainable financial plan for the GBRCN this
hinges on the success of securing signatures to the GBRCN MoU and getting the associated financial support.
Stratified approaches as described in Figure i.2, in the Executive Summary can provide a
model for network funding and help establish a global effort through linkage of levels. In
this respect, regional efforts, such as e.g. MIRRI, a pan-European research infrastructure,
would link into GBRCN and help it deliver its overall goals. This demonstrates how existing
funding mechanisms can be utilised to fund networks. It is absolutely critical that more
is done to identify funding mechanisms for BRCs. This needs careful consideration at the
national level but again participation in the global activity can help leverage the neces-
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sary funding as a positive output. Overall this work package provided a learning exercise
and provided some lessons for future efforts in providing financial sustainability.
4.5. RECOMMENDATIONS FOR THE SUBJECT OF THE WP WITH REGARDS TO
A FUTURE GBRCN
4.5.1. The instruments of establishment developed in the GBRCN Demonstration Project
contain relevant financial aspects and should be used to establish the GBRCN
4.5.2. The GBRCN business plan should be modified taking into account deliberations in
regional efforts such as MIRRI
4.5.3. The generic business plan should be adopted to suit national and individual BRC
needs and the funding mechanisms available to them
4.6. LIST OF ANNEXES
38
•
BRC funding models Document GP-WP-0008a (see electronic Annex)
•
The GBRCN model business plan GP-WP-0068 GBRCN (see electronic Annex)
•
GBRCN Architecture document GP-WP-0013 (see electronic and printed Annex)
WORK PACKAGES
5. WORK PACKAGE 5: CAPACITY BUILDING IN INFORMATION TECHNOLOGY
5.1. ORIGINAL AIMS AND OVERVIEW OF PROPOSED WORK
A vital task of the GBRCN demonstration project was to establish an information system
as a gateway portal to the partner collection strain databases enabling networked operational activities and provision of data, as well as information services to users. The information system, established as a portal, should provide tools to help the member BRCs to
manage their data and harmonisation of rules will facilitate interoperability and provide
a common data quality. In addition the portal should link to other data sources to help the
users of the member BRCs to understand the potential of the biological material and aid
and increase its utilization. To support this aim, the information system should facilitate
access to the knowledge and expertise of BRCs.
The envisaged data portal should be equipped with a virtual catalogue which can be set
up utilising standard interfaces, to avoid the member BRCs having to reform their data
systems. To deliver access to BRC distributed databases GBRCN will work with existing
initiatives, and tools such as StrainInfo.net, MycoBank, GBIF, WDCM and CABRI will be
considered.
To facilitate access to the assets of biological resource centres to a larger user community,
it is of utmost importance to create a virtual catalogue that provides seamless access to
all collection catalogues through a single portal interface. Culture collection databases
must be interlinked utilising as many interlinked tables and fields as needed to deliver
the OECD agreed minimum data sets. Integration of the underlying information is essential, in order not to overload the end user with duplicate information and to enable the
implementation of solid cross-reference schemes with information provided by thirdparty providers. Given the dynamic nature of the information, rapid synchronization of
the information flow between the collection catalogues and the virtual catalogue must
be guaranteed. On the technical side this requires the design and implementation of a
standardized information exchange format, through which individual collections expose
their data. On the user side this additionally requires a seal of quality for all data and data
providers to underpin confidence in the GBRCN information system.
The overall goal of the work package was to establish a model virtual GBRCN:
•
being open to all user groups, like BRCs, science, industrial R&D, commercial users, policy
makers
•
with worldwide accessibility to information and biological material in compliance with
legislation
•
co-ordinating and combining catalogues and databases
•
with worldwide linkage to open up opportunities and to provide rapid access to expertise
5.2. SUMMARY OF WORK DELIVERED
To reach the goals of the work package an overarching GBRCN information system that
effectively links collection systems or other networks to provide the virtual GBRCN was
defined. A model virtual GBRCN with member data access via a web information portal
(D1 part 2) was supported by participants in an international IT-cluster meeting between
seven project partners and invited international experts from academia and industry.
Rules for validation and information exchange are accompanying the ongoing process of
designing the most acceptable concept.
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Figure 5.1 The GBRCN Cluster Approach
The GBRCN demonstration project presented a model platform based information
system and defined the prerequisites of such a comprehensive approach, including adoption of internationally agreed standards and protocols, data flagging and data cleaning
tools and stable and long term funding as key factors for a successful development and
acceptance.
Figure 5.2 The GBRCN Model Platform Based Information System
The model already indicates that besides the technical solution, a steering unit is needed
to accompany the integration of data from collections with a low performance technical
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WORK PACKAGES
environment (low and/or unstable internet connectivity, using basic hardware, no
computer expertise) or to keep control over the data provided to the network at the site
of the providers. As the integration of services, communication tools and knowledge base
requires permanent staff, the virtual GBRCN can only be partially virtual. In addition collecting primary data from all taxa and from distributed collections using different software in diverse environments is a huge coordination and technically challenging effort
despite synergies with other initiatives. Thus sustainable funding is a crucial factor for
the existence and confidence in the virtual GBRCN platform. The potential of the system
with its overarching linkage and the capability to form a global community cannot be
under-estimated. In an IT-oriented era, the GBRCN must develop a comprehensive virtual
operating centre answering the most prevalent demands of users and providers within
one system. Still with today’s very well developed and elaborated networks, users express
the need to overcome geographic and strategic borders in favour of a central address offering all relevant data, information, knowledge and communication by intelligent search
and linkage routines.
5.3. KEY OUTPUTS WITH REGARD TO DELIVERABLES
One of the key outputs is that each potential strategy for data integration has its pros
and cons and thus only a system, incorporating attributes from all the most appropriate strategies, can provide the utmost of flexibility which is especially needed at the
data provider’s side, which are the collections themselves. The following strategies were
defined as the most appropriate ones:
•
Periodically export data to a central database
•
Real time distributed queries
•
Data harvesting
In addition with regards to standards and protocols there are several recommendations
the GBRCN Demonstration Project evaluated for the envisaged system:
•
Usage of existing standards whenever possible, to save considerable time and to avoid
interoperability issues in the future
•
Seek compatibility with other initiatives to benefit from existing tools and to get extra
functionality/data
•
Data providers should be the pillars of the network, thus the GBRCN system should help
improve their data, should ensure that data remain curated at the source and to show
that data sharing promotes citation and usage and thus gives the collections credit and
visibility
The last recommendation illustrates the two most important points, which should be
targeted by the GBRCN information system:
•
Providers must see the benefit of participation in the network (increase their visibility)
•
Users must see the added value of combined information and services generated from
trusted providers (decrease of search efforts and data failure)
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5.4. CONCLUSIONS
The GBRCN information system can only be successful if it is aligned with:
•
addressing all user groups
— BRCs, science, industrial R&D, commercial users, policy makers
•
worldwide accessibility to information and biological material
— coordinating and combining catalogues and databases
— coordinating curation, development and networking of informatics tools for data analysis,
comparison and visualisation
— establishing standards of similar quality with respect to data
— integration of associated databases in various disciplines (genetics, biochemistry, etc.)
•
worldwide linkage to open up opportunities and to provide rapid access to expertise
— for collaborative research
— for technology transfer
— to foster education and training (capacity building)
•
network strategy eliminating the limitations on information flows and provide one-stop
access to pertinent information and biomaterials
•
facilities providing a resource for public information and policy formulation
A future GBRCN information system should support these demands and should implement
a system offering a benefit and user driven added value for all user groups - embedded in
continuous quality management and strong policies giving all providers and users confidence and trust in the global virtual institution GBRCN is offering.
5.5. RECOMMENDATIONS FOR THE SUBJECT OF THE WP WITH REGARDS TO
A FUTURE GBRCN
5.5.1. The future GBRCN establishes an information system that encompasses the above
findings, is interoperable with other data sources to facilitate access and use of microbial
resources.
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6. WORK PACKAGE 6: DEVELOPMENT OF ADDITIONAL,
SUPPORTING PROJECTS
6.1. ORIGINAL AIMS AND OVERVIEW OF PROPOSED WORK
This work package was designed for the secretariat to seek funding opportunities to
secure projects for developing the network, strengthening the coordinating secretariat and
supporting the partners. The aim was to enhance the products from the work packages
and to provide model ideas how the future GBRCN might collate different matching
funding strategies. Where appropriate, the Secretariat would also link to on-going projects
to share output and achieve synergy. In particular the Secretariat sought to
•
find further financial components for the information system and web portal
•
have an e-learning tool project in place with CABI and other partners
•
identify further EU proposals for collaborative research and development, for example in
the area of genetic integrity of preserved strains, added value characterisation, molecular
identification/taxonomy, preservation technology, bioinformatics or networking tools
•
secure a further two projects to provide additional funding to enhance the outputs of the
demonstration project
6.2. SUMMARY OF WORK DELIVERED
The secretariat worked with partners to bring together additional proposals for submission for funding to enhance the output from the project. This has led to a series of project
ideas some of which were submitted and others are being kept as future proposals to
funding agencies.
The Secretariat also linked into on-going projects to share output and achieve synergy.
E.g. work with CABRI, WDCM, Straininfo.net and Biolomics was used to establish the web
presence and linked BRC databases. CABI has agreed for GBRCN to utilise its Managing
Microbes e-learning tool in its capacity building, particularly in countries of developing
economies. Future collaboration has been discussed e.g. with consortia that run or establish sequence databanks and genome projects such as GEBA and the next phase Microbial
Earth Project.
6.3. KEY OUTPUTS WITH REGARD TO DELIVERABLES
Some opportunities were identified and proposals and submissions made. The GBRCN
secretariat had contacted UNESCO and submitted a project outline on the establishment
of the Global Biological Resource Centre Network Capacity Building programme in Africa.
This aimed to enhance the capability of countries to identify, understand, conserve and
sustainably utilise genetic resources for research and development in the life sciences.
The proposal described scenarios on capacity building linked to the establishment of a
Global Network and covered human resource development, facility enhancement and
operational tool development in both the network and individual BRC. Unfortunately this
was not considered.
Similar project drafts had been submitted to the Ugandan National Council for Science
and Technology (NCST), the UK Department for Environment, Food and Rural Affairs, the
Darwin Initiative (x2) the JRS Biodiversity Foundation (2 calls answered) and the CABI
Development Fund, again without success.
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An effort to link all US American microbial germplasm repositories including NSF and USDA
supported ones, has been coordinated by Prof. Kevin McCluskey, Curator FGSC, University
of Missouri, Kansas City. This Research Coordination Network (RCN) submitted to the
National Science Foundation, Directorate for Biological Sciences, Division of Biological
Infrastructure will link USA culture collection networking activities with the GBRCN.
Although this proposal was rejected in a first round it has now been recommended for
full funding by the NSF.
A call in June 2010 from EC e-Infrastructures Capacities Programmme was considered
which would have offered an opportunity for developing the GBRCN information system.
A draft outline proposal had been developed by Prof. Tom Dedeurwaerdere, Catholic
University of Louvain and Prof. Peter Dawyndt, University of Gent and shared with the
GBRCN Secretariat. Due to the expected overwhelming competition in this call, the idea
was dropped.
The first successful action was to work with European partners to secure the EMbaRC
project. This is an EU project funded under the Seventh Framework Programme Research
Infrastructures (INFRA-2008-1.1.2.9: Biological Resources Centres (BRCs)) for microorganisms. It aims to improve, coordinate and validate microbial resource centre (MRC) delivery to European and International researchers from both public and private sectors. The
EMbaRC project is a mixture of networking, access, training and research. This project
helps funding of most of the European partners in the GBRCN to help deliver the common
networking goals. The research part of the EMbaRC project is outside the area of collaboration, this will deliver new methods for strain and DNA preservation, novel techniques
for identifying species and high throughput screening for enzymes of industrial interest.
However, the networking elements that are designed to give better access to authentic
microorganisms and validated associated data and provide a set of business models to
increase self-sustainability of BRCs enables European input.
A further two projects secured to provide additional funding to enhance the
outputs of the demonstration project
East Africa
Facilitated through a supporting project, the integration of partners from Kenya and new
contacts in Namibia to GBRCN was enabled. This was funded within the framework of
the German Federal Government‘s Strategy for the Internationalisation of Science and
Research (see http://africa.gbrcn.org/). The goal was to enhance African developments
towards political frameworks for the handling of biodiversity, the conservation and usage
of microbial diversity and the establishment of national BRCs. The GBRCN network was
enriched by the African view and was able to structure activities in the topics around
capacity building in a more focussed way. In Kenya, this has triggered renewed activities supported by the NCST (National Council for Science and Technology). These will
lead to a short term pilot project to build up a Kenyan Microbiological Culture Collection
Centre (KMCCC) which on the long run will lead to the long-term project of the establishment of a national BRC. A seminar and a workshop were held in Nairobi as part of the
project. The Seminar brought key proponents of BRC establishment in Africa together
with GBRCN and other experts in various fields. The main participants were from Kenya
with representatives from Nigeria and Uganda making contributions. There was an excellent community spirit shown during the week which enabled the driving forward of the
proposal to establish a Kenyan BRC and supporting network. In the follow-up Workshop
substantial effort was made working with the Kenyan National Council for Science and
Technology and other stakeholders such as KWS (Kenyan Wildlife Service) and NEMA
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WORK PACKAGES
(National Environment Management Council) to establish facilitating policy. Professor
Hamadi Boga, JKUAT, will lead the developments and will establish an African linkage
to include Namibia, Nigeria and Uganda so that these too can share the Kenyan development for their local implementation.
Figure 6.1 GBRCN Seminar, Kenia 2011
A most pressing issue in this context is the Nagoya Protocol on Access to Genetic
Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization
to the Convention on Biological Diversity. This was agreed at the Tenth Conference of
the Parties (COP 10) to the Convention on Biological Diversity (CBD) in October 2010. It
offers a framework to regulate access and benefit sharing at the national level. It aims to
ensure legal certainty for providers and users of genetic resources and associated traditional knowledge. Implementation of the Protocol will underpin the third objective of the
Convention of Biological Diversity (‚the fair and equitable sharing of the benefits arising
out of utilization of genetic resources’) and make an important contribution to sustainable development. However, it is essential that the GBRCN works with its partners to
gather and analyse information to assess risks to implementing the protocol and what
practical solutions are needed so as not to impede the work of BRCs to share resources,
not to impede generally access to and exchange of biological resources, and thus not to
impede research in bio-sciences and development in bio-economy. This may present a
more complicated future for the legitimate use of genetic resources and is an area that
needs further work by the GBRCN.
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MIRRI – the Microbial Resource Research Infrastructure
A major success on the European level was that the Microbial Resources Research
Infrastructure (MIRRI) has been placed on the ESFRI Roadmap 2010 and will provide a
global signal for BRC developments.
Submission of the MIRRI proposal to ESFRI was done by the French ESFRI delegate based on
the proposal text that had been designed by the GBRCN Demonstration Project Secretariat.
The MIRRI (Microbial Resources Research Infrastructure) initiative was judged as a mature
project and evaluated highly. See BMS-Report at http://ec.europa.eu/research/infrastructures/index_en.cfm?pg=esfri. Following the success of being accepted, the preparation of
the proposal for the MIRRI Preparatory Phase project (EU call of July 2011 and deadline 23
November 2011) occupied a significant proportion of GBRCN Demonstration Project staff
time. As of April 2012 the positive response from EU to fund the project was received.
MIRRI will enter the first of three predefined phases (preparatory, construction and operational phases). This phase focusses on steering mechanisms and structures, that contain
technical, legal and financial aspects and will build upon the foundations laid by the
OECD BRC Task Force, the GBRCN Demonstration project, the European EMbaRC project
and voluntary, scientific-technical collection networks, such as WFCC and ECCO. The
central coordination will be exerted through the present seat-institution of the GBRCN
Demonstration project, the DSMZ.
Developing structures and strategies will require sound coordination of work. The expertise gathered during GBRCN work will be harnessed.
Figure 6.2 MIRRI Europe: MIRRI Partnership is strongly based on ECCO Collections participating as
partners or contributing as associated partners in the Preparatory Phase
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6.4. CONCLUSIONS
While long term core funding is needed for a GBRCN to deliver meaningful results, it
certainly is necessary and appropriate to design a mosaic of various types of support
around this core infrastructure funding. Proposals designed in order to address various
network functions including enhancing scientific capacity of the cooperating entities,
enhancing managerial and performing capacities, or for improving accessibility to the
biological material. During the project phase, it was confirmed by all partners that it was
difficult to locate long-term infrastructure related funding opportunities amongst the
current focus on research funding.
A substantial number of proposals had been submitted by the GBRCN Demonstration
Project Secretariat (as described above) over the project life of 3 years despite having
restricted time for doing so. These were prepared partially in cooperation with all or
some individual partners. Three of these proposals resulted in funding, a success rate
of about 30% which is an excellent result considering the strong competition for diminishing resources and opportunities. Some individual partners submitted projects to
support their GBRCN work to their national funders, some were secured e.g. in Brazil but
unfortunately failed in Spain.
Additionally, the interest of initiatives to cooperate with GBRCN led to consortium proposal
submissions outside but related to the GBRCN. Such a project was secured in the USA.
In a future GBRCN such varied projects would help fund the suggested cluster operations
of the network which would be essential for its coordinated output, its operation framework and its internal functioning.
6.5. RECOMMENDATIONS FOR THE SUBJECT OF THE WP WITH REGARDS TO
A FUTURE GBRCN
6.5.1. Secured long-term core funding is a prerequisite for the long-term duties of a
GBRCN secretariat
6.5.2. Associated seed money should be secured to trigger activities at BRCs, which
otherwise would be difficult to fund by the normal research funding mechanisms; e.g.
authentication of extant holdings of BRCs, or applying appropriate preservation methods
6.5.3. Matching short-term funded projects should be sought for particular activities to
supply development
•
in individual countries
•
in individual regions
•
for activities of global relevance such as the web portal
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6.6. LIST OF ANNEXES
•
Websites
africa.gbrcn.org
www.mirri.org
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OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
IV. OVERALL GBRCN DEMONSTRATION
PROJECT CONCLUSIONS
Overall, the Work Package aims have been met and the deliverables have been judged
useful for the establishment of the GBRCN. The only drawback from the original aims is
that no direct government commitments could be firmly secured to support a GBRCN in
the future, although a number of very positive estimations from this side were received.
One reason for this may have been that it would be much easier for politicians to support
at the national level rather than regionally or globally. Transferring funds across national
borders seems to be very difficult. The present economically strained situation in many
countries around the world accounted for another main reason for this lack of responsiveness. However, at the recent International Conference on Research Infrastructures,
21 – 23 March 2012 in Copenhagen, the need for expanding European Infrastructures to
reach the global level was clearly stated. This might trigger a renewed interest in expanding the established GBRCN model into a fully performing infrastructure. Other success
was demonstrated in the funding of related activities both instigated by the demonstration project secretariat and its partners.
1. IMPLEMENTATION OF BEST PRACTICES AND CAPACITY BUILDING
It was clear that quality management was the very core of operational work of each
partner collection or BRC. All main activities: to create repositories for biological material,
to make this authentic material accessible and to provide users with validated data need
to be based on a strong quality management system which is defined by global demands.
The project outputs demonstrate a significant need to facilitate:
•
incorporation of the variety of different BRCs types that originate from university based
laboratories or independent, company structured organizations and their different funding
structures
•
more detailed and sustainable assistance in interpretation and implementation of the
OECD best practice guidelines
•
setting up universally valid master procedures and creating a library of Standard Operating
Procedures
•
defining codices and operational agreements
•
rolling out the certification procedure based on the excellence model
•
establishing a capacity building center to support the developing BRCs Data resources and
information systems
2. DATA RESOURCES AND INFORMATION SYSTEMS
The GBRCN information system can only be successful if it is aligned with:
•
addressing all user groups
— BRCs, science, industrial R&D, commercial users, policy makers
•
worldwide accessibility to information and biological material
— coordinating and combining catalogues and databases
— coordinating curation, development and networking of informatics tools for data analysis,
comparison and visualization
— establishing standards of similar quality with respect to data
— integration of associated databases in various disciplines (genetics, biochemistry, etc.)
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OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
•
worldwide linkage to open up opportunities and to provide rapid access to expertise
— for collaborative research
— for technology transfer
— to foster education and training (capacity building)
•
network strategy eliminating the limitations on information flows and provide one-stop
access to pertinent information and biomaterials
•
facilities providing a resource for public information and policy formulation
A future GBRCN information system should support these demands and should implement
a system offering a benefit and user driven added value for all user groups - embedded
in a quality management culture and strong policies giving all providers and users confidence and trust in the global virtual institution GBRCN is offering.
3. LEGISLATION COMPLIANCE AND OPERATIONAL FRAMEWORK
Different parts of the world have addressed legal issues of relevance to BRCs to different
degrees and with different priorities. This is a vast area and needs legal experts to assist
in interpretation and guidance to deliver a compliant operational framework for BRCs.
Additionally, legislation does change and BRCs need to keep abreast of this. The GBRCN
Demonstration project focussed its outputs to enable key aspects to be addressed more fully.
The project partners agreed that Biosecurity was of significant relevance, specifically its
risk assessment. This aspect tended to be over-estimated in its demands. It is clear that
risk assessment is based on what is known and a BRC needs to be aware of published and
generally available information to be able to carry out a suitable risk assessment. Actual
in depth research is not demanded. To aid in the general implementation of biosecurity
practices and raise awareness, the Biosecurity Code of Conduct (CoC) was developed,
tested and verified as a key tool in control of dual use. It received BTWC Review Conference
endorsement. This CoC works well for BRCs both in countries with and without legislation but this can only be a starting point. The CoC highlights awareness and key principles, while the OECD Best Practice Guidelines on Biosecurity for BRCs remain the key
document in its implementation. This together with the WHO documentation on the topic
would also provide suitable tools for countries without comprehensive legislation.
The Nagoya Protocol on Access and Benefit Sharing (NP) of the CBD lays down requirements concerning Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT). The
principal requirement is that “benefits arising from the utilization of genetic resources
as well as subsequent applications and commercialization shall be shared in a fair and
equitable way with the Party providing such resources that is the country of origin of
such resources or a Party that has acquired the genetic resources in accordance with
the Convention” (Article 5). The implementation of the NP may well impede access and
exchange of materials and information. In this context the collection community will
have to work towards a mutually beneficial multilateral operational framework to facilitate and not inhibit science and the discovery process.
The information review and delivery resulting in documents on the GBRCN Demonstration
Project web site highlights requirements that BRCs must implement in order to comply
with legislation. This helps prepare candidate participants in the GBRCN to implement
the key principles of being a BRC i.e. compliance with such legislation. The comprehensive
Biosecurity Code of Conduct for BRCs is a model key element in the legislative compliant
operational framework for the GBRCN. Further work is needed to develop similar approaches in other areas of legislation compliance for BRCs.
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OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
4. FINANCES AND SUSTAINABILITY
The GBRCN MoU (document GP-WP-0008) describes structure and governance of the
future GBRCN, providing the key tool for establishment and presents a financial model
based on national contributions to support the running of the Secretariat and its work.
Having agreed this sustainable way forward for the Secretariat different levels of participation were anticipated (see Table 4.1 Elements of Government participation in GBRCN).
Generic business plans were designed for use both by the project partners and by culture
collections in general. However, the individual BRCs have different national operational environments and the possible funding mechanisms are quite different. Although
some partners reported that they had a higher profile through the participation in the
Demonstration Project which facilitated some additional financial support, little could be
done centrally other than to provide a generic support in rationale and possibilities for
funding models.
A sustainable financial plan for the GBRCN hinges on the success of securing signatures
to the GBRCN MoU and getting the associated financial support. The vital connections to
funders were not made during the project life of the GBRCN Demonstration Project. How
existing funding mechanisms can be “tapped” to fund networks might be demonstrated
by MIRRI – a pan-European research infrastructure – that would represent one regional
sub-layer of GBRCN. MIRRI could help GBRCN to deliver its overall goals and can provide a
model to be replicated regionally to help establish a global effort through their linkage.
Partners expressed the need to look for additional sources of funding, e.g. related to the
possible commercial uses of the strains they hold.
While long term core funding is needed for a GBRCN to deliver meaningful results, it
certainly is necessary and appropriate to seek various types of support around it to
fund various activities. E.g., the cluster or expert group activities within the network
that would address enhancing scientific capacity of the cooperating entities, enhancing
managerial capacities, or for improving accessibility to the biological material. During
the project phase, it was confirmed by all partners that it was difficult to locate long-term
infrastructure related funding opportunities. However, this project demonstrates that
targeted activities of a central secretariat can be very constructive in this respect. The
GBRCN secretariat submitted 10 proposals over the project life which resulted in funding
for 3, a success rate of 30%, an excellent result considering the strong competition for
diminishing resources and opportunities. Associated with this, partners were involved in
consortium submissions related but outside the GBRCN with 3 successful of the 4 submissions. Projects were secured in Brazil and USA with a proposal in Spain unfortunately
failing. Such additional short term project funding is necessary to help fund the network
development and its operations.
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
51
Final Report on the GBRCN Demonstration Project
OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
5. OUTREACH
Presentations and publications publicised the output from the GBRCN Demonstration
Project. Six publications were produced and more than 30 meetings/conferences (7 organised by GBRCN) were attended in 18 countries delivering more than 100 presentations.
Interactions at the Government representative level
The GBRCN secretariat together with ECCO and EMbaRC representatives had successful
interactions with ESFRI representatives to establish MIRRI on the ESFRI roadmap. This
resulted in an EU funded Research Infrastructure project.
A great recognition of GBRCN work was received by the Biological and Toxic Weapons
Convention’s seventh review conference invitation to present the Biosecurity Code of
Conduct for BRCs.
The Directorate for Science, Technology and Industry Committee for Science and
Technology Policy, Biotechnology Unit of the OECD invited the GBRCN to provide input on
biosecurity developments and policy.
Examples for Specific Partner Interactions
Brazil
Brazilian Ministry of Science, Technology and Innovation (MCTI) – national
funding secured
Brazilian microbial resource collections involved in governmental committees,
groups and meetings concerning the Brazilian Policy of Biotechnology and
Biological Collections, biosafety legislation and Biodiversity
Spain
Spanish Ministry of Science and Innovation (MICINN) – support for facility
enhancement
Taiwan
Ministry of Economic Affairs, Republic of China, Taiwan – national support and
support for GBRCN Secretariat
UK
Department for the Environment, Food and Rural Affairs – will participate in
MIRRI and involves UK microbial resource collections in stakeholder meetings
on relevant policy
Interactions with the user community
GBRCN took up relations with BBMRI - Biobanking and Biomolecular Resources Research
Infrastructure and other RIs as well as with e.g. EUPHRESCO – a phytosanitary ERA-Net
which is a network of national research funders of plant health. Likewise contacts were
made to scientific associations such as IUMS on the global and FEMS on the European level.
Examples for Specific Partner Interactions
Brazil
Brazilian Society of Microbiology (SBM)
Portugal
Portuguese Bio-industries Association
Portuguese Society for Microbiology
Portuguese Society for Biotechnology
Germany
Association for General and Applied Microbiology (VAAM)
Association of Biological Societies (VBio)
UK
52
Society for General Microbiology
OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
Networks and partnerships established
Brazilian Biological Resource Centre Network
Brazil
Coleção Brasileira de Microorganismos de Ambiente e Indústria (CBMAI) established a highly improved relationship with collections of the global network (DSMZ,
UMinho MUM), that allowed the training of staff, among other activities
Colecao de Leishmania do Instituto Oswaldo Cruz (CLIOC) is now serving as a
model for the other microbiological collection maintained at Fiocruz
Finland
Finnish Microbial Resource Centre Organisation (MICCO)
Germany
Leibniz-Gemeinschaft
PARTNER EXPECTATIONS AND REPORTED IMPACTS
GBRCN influence on the Brazilian network: The collaborative opportunities derived from
the implementation of the GBRCN demonstration project were critical to the development of the Brazilian capacity building program which was focused on the improvement
of quality management and testing of the OECD guidelines in selected Brazilian collections, i.e. BRC candidates. The training of Brazilian experts from CBMAI and TECPAR at
CABI and DSMZ and the facilitated exchange of ideas and experiences were key to further
advance the implementation of the Brazilian BRC Network. The GBRCN in-kind support
for the organization of outreach events in collaboration with the Brazilian Society of
Microbiology (SBM) at the 2009 Porto de Galinhas SBM Congress, followed by the 2010
WFCC ICCC-12 in Florianópolis and the 2011 SBM Congress in Foz do Iguaçu, Paraná, were
fundamental to raise awareness on the importance of a consolidated infrastructure of
resource centres to foster innovation in science and technology. In all these events, the
participation of officers from the GBRCN Secretariat was fundamental to present policy
trends and state of art developments at global level. Influential inputs were:
1. MCTI support to the implementation of the capacity building program focused on the
improvement of quality management, associated with the development of the information system
2. The Tecpar support to implement the quality management program and the evaluation of
the OECD guidelines in selected collections
3. The effort of Inmetro in guiding quality management developments
4. The political support of INPI
5. In conclusion, the effort to articulate the participation of major
governmental players (such as
Fiocruz, Embrapa, Inmetro and
INPI) and the focused involvement
of
CRIA
and
Tecpar,
proved that the consolidation of
the institutional arrangements
under implementation will be
key for the consolidation of the
Brazilian BRC Network (BBRCN)
The GBRCN Model Audit Team at CBMAI,
Campinas, Brazil in 2009.
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
53
Final Report on the GBRCN Demonstration Project
OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
TECPAR and INMETRO: Before the start of the GBRCN Demonstration Project, the work
carried out by TECPAR was focused on the assessment of the management procedures
to help collections adjust their quality management systems, taking into consideration
the OECD Best Practice Guidelines (BPG). This work was followed up with the identification of the key activities performed in the collections that would be the object of conformity assessment taking into account the OECD BPG and ISO standards. The proposal to
the Brazilian Accreditation Body (Cgcre/Inmetro) was based on the efforts of the CT-CRB
containing the structure of a conformity assessment program for BRCs. This system
in Brazil includes a third party assessment and follows the guidelines of the Brazilian
System of Conformity Assessment, approved by the National Council of Metrology,
Standardization and Industrial Quality (Conmetro). It is structured to contain a set of technical procedures which result in the issuance of documents evidencing the compliance of
biological resource with the specified requirements. The proposed system is aligned with
the recommendations available at the Presidential Decree 6041 on the National Policy for
the Development of Biotechnology and the OECD BPG for BRCs.
Key Brazilian outputs are:
•
CBMAI and BCRJ will be operating in the new facilities in 2013
•
It is expected that CBMAI and CLIOC will be able to meet the requirements necessary for
the accreditation by Inmetro in 2013
•
The regulatory framework for the accreditation of resource centre candidates to acquire
the BRC status will be in place in Brazil by the end of 2012
•
It is expected that the INPI Depository Authority for patent purposes that is being built at
INMETRO campus will be in operation in 2013
The Brazilian effort to improve the quality management in service collections is a step
forward in the consolidation of the BBRCN. The advances are a consequence of the implementation of the information system, the definition of mechanisms for third party assessment, and the procedures for the accreditation of resources centres structured to put in
the foreground the demonstration of the technical competence of a BRC in developing
their activities. The plan to consolidate the BBRCN takes into consideration all aspects
relevant to metrology, standardization and conformity assessment according to the
Conmetro recommendations. These advances are a result of the collaboration undertaken
by the partner institutions (national and international) during the implementation of the
demonstration project, under the coordinating GBRCN Secretariat team. Without the work
carried out by the GBRCN Secretariat staff (funded by the German Government) it would
not be possible to develop the required collaborative work in a coordinated fashion.
CRIA: The new insights brought by the coordinated participation of a number of key partners in the GBRCN project and the advances achieved at local level, show the importance
of the work carried out by the GBRCN Secretariat officers. The improvement of institutional
coordination and the development of new political arrangements show that the GBRCN
project had a major impact in the development of the Brazilian BRC Network. CRIA’s work
was focused on the further development of the micro-Sicol software and the implementation of SIColNet. Micro-SICol is a collection management software to support digital documentation and traceability of all processes associated with day-to-day management of
microbial collections. The software is a multiplatform system, designed to be compatible
with different data management systems. It is multi-user and multi-language and supports
the installation of multiple collections and sub-collections. It is designed to document
specific fields of importance to microbial collections based on the WFCC Guidelines for
Operation and Management of Collections of Cultures of Microorganisms (Second Edition,
1999), the Common Access on Biological Resource and Information (CABRI) Guidelines
54
OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
and the OECD Guidelines for Quality Management. SIColNet allows the dynamic integration of strain data available in Brazilian collections with relevant information sources,
ranging from molecular to ecosystems databases. Alignment with emerging technologies
and adoption of internationally agreed standards and protocols to secure systems interoperability are key features of SIColNet architecture.
BCCM: The project was induced by OECD recommendations at official levels and worked at
a scientific level. Building links between decision making level, governing administration
and operational level is difficult and could not be secured in this project because it was
built around bottom-up actions with too few inputs from decision making participants.
BCRC: It’s good to see the outcome of having the MoU and the efforts of connecting to
other domain initiatives.
BCRJ: We consider that the GBRCN is well elaborated, is consistent and unresolved
matters will be solved without great impact or changes in the project main content.
There is a group of professionals with vast experience and great recognition which is
able to actively and decisively contribute to the success of this enterprise. Brazilian effort
will continue through the consolidation of the Brazilian Network of Biological Resource
Centres (BNBRC). BRCs will follow international regulations and the OECD BPG, being able
to offer authentic biological material, the required associated information, the management system of quality in and environment ensuring biosecurity and biosafety. This
should create the ability to contribute effectively to the GBRCN. Following the initial steps
in organizing the BNBRC, the BCRJ has identified the necessity to move from its position
within the academic and hospital environment into a national institution open to biomedical, technological and industrial applications of animal and human cell cultures. This
was done with the transfer of BCRJ to INMETRO, the national institute responsible for the
quality control, able to answer to national demands of biological materials of controlled
quality. Participation in the present program has largely facilitated implantation of BCRJ
within this new environment. The BCRJ will participate in accreditation of institutions
and enterprises in Good Laboratory Procedures, as well as in preparing the set of Certified
Reference Materials within the area of animal and human cells, following the ISO GUIDE
34. BCRJ expects new national programs of support will be created to contribute to the
sustainability of the collections.
BCRJ short term expectations are:
•
That the formation of the GBRCN brings positive influence to the Brazilian Government
Guidelines in order to concentrate efforts on creating a long-term national program adding
to the national collections
•
That the four founding collections the BNBRC get the accreditation based on the ISO IEC
17025 regulation and the OECD BPG
•
Concerning BCRJ specifically, moving to new facilities in 2012 will improve working
conditions and developments of new projects
CABI: Overall the GBRCN Demonstration Project has been extremely successful. This is
exemplified by recognition by the ESFRI national delegates and the European Commission
when establishing MIRRI on the ESFRI roadmap and the Biological and Toxic Weapons
Convention’s seventh review conference delegates who welcomed and endorsed the
Biosecurity code of conduct for BRCs. The project has made a major breakthrough in
helping microbial resource collections demonstrate their value and shown how their
networking can lead to the better management of resources and their improved delivery into research and development. The UK Government has renewed interest specifically from Defra who have agreed to work with MIRRI. CABI is proud as an international
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
55
Final Report on the GBRCN Demonstration Project
OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
organization to work in partnerships and the work of the GBRCN Demonstration Project
has strengthened its relationships in the area of ex situ microbial diversity management
and use. CABI wanted to be part of the establishment of a global network that had a high
profile and filled gaps in its own needs for reference materials and expertise which would
help provide a sustainable future for its living collections. The future GBRCN and related
projects and activities have the potential to do all these things, and linking to similar
initiatives already underway elsewhere will help establish the GBRCN at a global level.
The GBRCN Demonstration Project should be proud of its delivery of networking tools,
policies and strategies which have been recognized at the highest levels. A meeting of
UK national collections is examining mechanisms to take up key GBRCN demonstration
project outputs.
CBMAI: The project was successful and allowed the improvement of CBMAI’s operation and management. Additionally, our participation resulted in: a. financial support
from National Agencies, Government and companies; b. the increment and expansion
of CBMAI staff; c. the beginning of an important link among Brazilian Collections and
the Government for the establishment of BBRCN. Therefore, making part of this international cooperation effort was a rewarding experience that enabled CBMAI and other
Brazilian Collections to grow and advance in this area. Since the new CBMAI building
could not be finished during the execution of the project, expectations were only partially fulfilled. However, the building is foreseen to be concluded by April 2012. Another
point is that, although the discussions for the national accreditation rules occurred, other
political issues must advance in order to reach a national legislation for BRCs recognition. It is assumed that the rules for accreditation will become official by the end of the
first semester 2012. Through ISO 17025 and OECD Guidelines implementation, CBMAI
has improved its administrative and operational activities, which were recognized by
the third parties, giving the collection more confidence. Besides, the software uSicol for
the management of the collection contributed for its organization, data traceability and
a rapid access to the microbial associated information. We consider that a phase 2 of
this project would be very much recommended in order to give continuity to the process
of GBRCN consolidation. For the future a) CBMAI intends to become a national BRC and
be part of the GBRCN; b) Secure further financial support through research projects; c)
Increase the services offered to clients in order to expand income; d) Secure Government
funding and political assistance for BRC recognition.
CBS: A good job was done, the more so when considering the limited manpower and
funds. Voluntary collaboration of BRC’s demonstrated their interest. Combination with
EU project EMbaRC was very successful. A major output was the Biosecurity Code of
Conduct and a supporting database is in a trial stage. CBS worked on this project with
pleasure and appreciated the very positive collaboration, especially with the secretariat
in Braunschweig.
CLIOC: The Fiocruz Leishmania Collection, a WHO Reference Collection, is being prepared
to be the core collection of the Fiocruz BRC. The CLIOC experience in the implementation
of procedures for quality assessment and improvement of quality management procedures, include the digital documentation process and implementation of procedures that
allow the traceability of processes and products. The CLIOC experience is being replicated
to the other culture collections at Fiocruz and the micro-SICol software is being tested by
11 of its collections. CLIOC’s expectations were thus attained. Since the inclusion of CLIOC
in the Brazilian BRC Network and future participation in the GBRCN, CLIOC is now operating in accordance to the rules defined by INMETRO, combining requirements of ISO/IEC
17025, ISO GUIDE 34 and OECD Guidelines. CLIOC anticipates accreditation by INMETRO
in 2012.
56
OVERALL GBRCN DEMONSTRATION PROJECT CONCLUSIONS
CRBIP: GBRCN was a real demonstration project, very useful for the following up of the
harmonization of the practice of all the collections. Specifically it helped in setting up
a quality system, supported collaboration with other European collections in different
aspects and help set up the EMbaRC project. It presents a good basis for a global network
of collections in connection with ECCO and WFCC. The best practice guidelines have to be
ubiquitous and need to be audited by an official national company of certification. One of
the most critical difficulties is finding a budget for the establishment of the network and
particularly the secretariat.
IST: The analysis of the OECD Best Practice Guidance, information on legislation, code of
conduct on bioescurity have influenced the operations of the collection, and this is true
for all collections in the network. The Demonstration project represents a successful effort
of bringing BRC from all-over the world to collaborate. The idea of a GBRCN came from the
work of the OECD Task Force on BRCs, in which we participated. Being involved in BRCs
in the human domain, IST is particularly interested in the common features between
BRCs in the microbial and in other domains (human, animal, plant). Expectations were
met by the Demonstration project, the links with the human domain project were built,
the meeting “Establishment of a Biological Resource Centre Network for human samples
following the OECD guidelines” was held in Vienna in November 2010 and now a GBRCNhuman project exists.
CECT: The idea of a Global Network for collections/BRC is very attractive from a theoretical point of view, but the great diversity among collections/BRCs concerning size, expertise, resources, status, etc. poses great challenges that will need a great amount of effort
from the collections/BRCs, and also help from experts. In past years, the collections have
normally interacted among themselves in an informal way, and only for specific aims:
exchange of strains, doubts about ‘critical’ points (IPR, MTA, techniques, etc.), based on
personal contacts. The Demonstration project wished to lay the foundations for a real
global approach. The first steps have already been taken with a quite satisfactory result,
but without much regulation, on a voluntary basis for partners and without much compromise. Thanks to other on-going funded projects, such as EMbaRC, many of the objectives
have been reached, but there is no guarantee of having always some simultaneous funded
project, and this is a critical point. Unfortunately, the economic situation in many countries is far from optimistic, and this means probably lack of financial support. Therefore,
all possible ways of increasing the BRC income should be explored and become a priority,
which is also coherent with the present need to diversify the offer. But, again, this means
an additional investment in effort and time. CECT has experienced important advances,
but these advances are fully dependent on the existence of enough funding, and this is
one of the main ‘critical points’.
VTT: The GBRCN project has been extremely useful for VTT Culture Collection and was
regarded highly within the VTT Technical Research Centre of Finland, its host institution.
It is hoped that the GBRCN will develop according to the outlined GBRCN MoU and GBRCN
Architecture, rationale and operation. The VTT Culture Collection will probably continue
to be financed by its host institution (as it has for the past 53 years). However, to be able
to strengthen the capacity building of the collection and to fully implement OECD BPG,
the resources are insufficient. Moreover, the national situation in the country requires
substantial improvement. VTT Culture Collection could be involved in building up a national network of MRC’s to support a prosperous biotechnology sector and flourishing environmental research and technology. The message about the necessity of MRC’s for the
society in enabling and promoting biotechnology, science and training is very hard to get
through to political contacts in economically strained times. The international collaboration of microbial BRC’s is very important in this respect.
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
57
Final Report on the GBRCN Demonstration Project
THE GBRCN DEMONSTRATION PROJECT PARTNERSHIP
V. THE GBRCN DEMONSTRATION PROJECT
PARTNERSHIP
Country
Institute
Belgium
Belgian Science Policy
Office (BELSPO, SPP-PS)
Belgian Co-ordinated
Collections of MicroOrganisms (BCCM)
Brazil
Contact Person
E-Mail
Philippe Desmeth
philippe.desmeth@belspo.be
Maria Helena
Bosschaerts
maria-helena.bosschaerts@belspo.be
BCCM/LMG
Danielle Janssens
danielle.janssens@ugent.be
BCCM/LMBP
Martine Vanhoucke
martine.vanhoucke@dmbr.ugent.be
BCCM/IHEM
Marijke Hendrickx
mhendrickx@wiv-isp.be
BCCM/MUCL
Stéphane Declerck
declerck@mbla.ucl.ac.be
Vanderlei Perez Canhos
vcanhos@cria.org.br
Centro de Referência em
Informação Ambiental
(CRIA)
Campinas State
University
Coleção Brasileira de
Micro-organismos de
Ambiente e Indústria
(CBMAI)
Valéria Maia de Oliveira
vmaia@cpqba.unicamp.br
University of Rio de
Janeiro
Rio de Janeiro Cell Bank
BCRJ
Antonio Martins
Monteiro
cellbank@hucff.ufrj.br
EMBRAPA
Microbial Culture
Collection
Rosa Maria Pitard
Instituto Oswaldo Cruz
(IOC)
Leishmania collection of
Oswaldo Cruz Institute
(CLIOC)
Claude Pirmez
pirmez@ fiocruz.br
Manuela da Silva
manuela.dasilva@ incqs.fiocruz.br
Canada
Agriculture and AgriFood Canada (AAFC)
Canadian Collection of
Fungal Cultures
Carolyn Babcock
babcockc@agr.gc.ca
China
The Institute of Agricultural Resources and
Planning of CAAS
Agricultural Culture
Collection of China
(ACCC)
Jingang Gu
jggu@caas.ac.cn
Institute of Microbiology, Chinese Academy of
Science (IMCAS)
China General Microorganisms Culture Collection CGMCC
Juncai Ma
ma@sun.im.ac.cn
Finland
VTT Technical Research
Centre of Finland
VTT Culture Collection
Erna Storgårds
erna.storgards@vtt.fi
France
Institut Pasteur
Centre de Ressources
Biologiques de l’Institut
Pasteur (CRBIP)
Chantal Bizet
bizet@pasteur.fr
Dominique Clermont
dclermon@pasteur.fr
(accc@ caas.ac.cn)
Germany
Leibniz-Institut DSMZ Deutsche Sammlung von
Mikroorganismen und
Zellkulturen GmbH
DSMZ
Dagmar Fritze
dfr@dsmz.de
UK
CAB International - CABI
CABI
David Smith
d.smith@cabi.org
Italy
Istituto Nazionale per la
Ricerca sul Cancro (IST)
(National Institute for
Cancer Research)
Interlab Cell Line Collection (ICLC)
Barbara Parodi
barbara.parodi@istge.it
Japan
National Institute of
Technology and Evaluation (NITE)
NITE Biological Resource
Center (NBRC) Department of Biotechnology
Ken-Ichiro Suzuki
suzuki-ken-ichiro@nite.go.jp
National Institute of
Genetics
World Data Centre of Microorganisms (WDCM)
Hideaki Sugawara
hsugawar@gmail.com
Jomo Kenyatta University of Agriculture and
Technology (JKUAT)
Institute for Biotechnology Research and
Botany/Microbiology
Department
Hamadi Iddi Boga
hamadiboga@yahoo.com
Kenya
58
Collection Name
THE GBRCN DEMONSTRATION PROJECT PARTNERSHIP
Netherlands
Royal Netherlands
Academy of Arts and
Sciences (KNAW)
Centraalbureau voor
Schimmelcultures (CBSKNAW)
Gerard Verkleij
g.verkleij@cbs.knaw.nl
Portugal
Universidade do Minho
- Micoteca da Universidade do Minho (UMinhoMUM)
UMinho-MUM
Nelson Lima
nelson@ie.uminho.pt
Spain
Universitat de Valencia,
Edificio de Investigacion
Coleccion Espanola de
Cultivos Tipo (UVEGCECT)
Esperanza Garay
Esperanza.garay@ uv.es
Taiwan
Food Industry Research
and Development
Institute
Bioresource Collection
and Research Center
(BCRC)
Yu-Fen Chen
yfc@ fi rdi.org.tw
Gwo-Fang Yuan
gfy@ fi rdi.org.tw
Makerere University
Kampala
Faculty of Veterinary
Medicine
Denis K. Byarugaba
dkb@vetmed.mak.ac.ug
Uganda
GBRCN Partners
in the world and interested parties
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
59
Final Report on the GBRCN Demonstration Project
GLOSSARY
VI. GLOSSARY
60
Acronym
Full Name
ABS
Access and Benefit Sharing
ACM
Asian Consortium for Microorganisms
AFNOR
Association Française de Normalisation
BBMRI
Biobanking and Biomolecular Resources Research Infrastructure
BCRC
Bioresource Collection and Research Centre (FIRDI)
BMBF
German Federal Ministry of Education and Research
BRC
Biological Resource Centre
BSL
Biological Safety Level
BTWC
Biological and Toxin Weapons Convention
CABI
CAB International (UK)
CABRI
Common Access to Biological Resources and Information
CBD
Convention on Biological Diversity
CBMAI
Coleção Brasileira de Microorganismos de Ambiente e Indústria
CBoL
Consortium for the Barcode of Life
CC
Culture Collection
CECT
Colleccion Espanola De Cultivos Tipo
CEN
Comité Européen de Normalisation
CoL
Catalogue of Life
CRBIP
Centre de Ressources Biologiques de l’Institut Pasteur (France)
CRIA
Centro de Referência em Informação Ambiental (Brazil)
CWA
CEN Workshop Agreement
DSMZ
Leibnitz-Institut Deutsche Sammlung von Mikroorganismen
und Zellkulturen
ECCO
European Culture Collections’ Organisation
EMbaRC
European Consortium of Microbial Resource Centres
EN
Europäische Norm
EoL
Encyclopaedia of Life
ESFRI
European Strategy Forum for Research Infrastructures
EU
European Union
EUPHRESCO
European Phytosanitary Research Co-ordination
FIRDI
Food Industry Research and Development Institute
GBIF
Global Biodiversity Information Facility
GBRCN
Global Biological Resource Centre Network
ICCC
International Conference for Culture Collections
INMETRO
Instituto Nacional de Metrologia (Brazil)
IP
Intellectual Property
ISO
International Standards Organisation
IT
Information Technology
MICCO
Microbial Resource Centre Organisation (Finland)
GLOSSARY
MIRRI
Microbial Resources Research Infrastructure
MoU
Memorandum of Understanding
MRC
Microbial Resource Centre
MUM
Micoteca da Universidade do Minho (Portugal)
OECD
Organisation for Economic Co-operation and Development
QM
Quality Management
SciColl
Scientific Collection International
SICol
Sistema de Informação de Coleções de Interesse Biotecnológico
SOP
Standard Operating Procedures
UNESCO
United Nations Educational, Scientific and Cultural Organisation
UNIDO
United Nations International Development Organisation
VKM
All-Russian Collection of Microorganisms
VTT
Valtion teknillinen tutkimuskeskus
WDCM
World Data Centre for Microorganisms
WFCC
World Federation for Culture Collections
WHO
World Health Organisation
WPB
Working Party for Biotechnology (OECD)
GLOBAL BIOLOGICAL RESOURCE CENTRE NETWORK
61
Final Report on the GBRCN Demonstration Project
ANNEX
VII. ANNEX
CITED DOCUMENTS
1. Document GP-PM-0008 GBRCN MoU (printed and electronic Annex)
2. Document GP-WP-0007a Analysis of CWA Biorisk Standard (electronic Annex)
3.
Document GP-WP-0008a BRC funding models (electronic Annex)
4. Document GP-WP-0013 GBRCN Architecture (printed and electronic Annex)
5.
Document GP-WP-0068 GBRCN Draft Business Plan (electronic Annex)
6.
GBRCN statement 7th_BTWC_Rev_Conf GSP-4 Rev1 (printed and electronic Annex)
7.
Self Assessment GBRCN all_General (electronic Annex)
8. Self Assessment GBRCN all_biosecurity (electronic Annex)
9.
Self Assessment GBRCN all_Micro (electronic Annex)
10. Code of Conduct for BRCs (electronic Annex)
ELECTRONIC ANNEX
If the usb card is lost, then you can download the documents from
http://www.gbrcn.org/login.html.
Username: gbrcnreport
Login: report2012
62
MEMORANDUM OF
UNDERSTANDING
FOR THE
GLOBAL BIOLOGICAL
RESOURCE CENTRE
NETWORK
© GBRCN Demonstration Project
Document: GP-PM-0008 GBRCN MoU based on GBIF MoU Version 2006
Version: 6.0
Page: 1 of 24
TABLE OF CONTENTS
Page
PREAMBLE...............................................................................
3
Paragraph 1
DEFINITIONS………………………………………………...
4
Paragraph 2
UNDERSTANDINGS………………………………………...
6
Paragraph 3
OBJECTIVES………………………………………………....
7
Paragraph 4
THE GOVERNING BOARD……………………………….....
9
Paragraph 5
THE GBRCN SECRETARIAT HOST.....................................
11
Paragraph 6
THE GBRCN SECRETARIAT.......…….……………….........
12
Paragraph 7
MANAGING DIRECTOR/ EXECUTIVE SECRETARY……
13
Paragraph 8
INTELLECTUAL PROPERTY....................................…….....
14
Paragraph 9
FINANCE...................................................................................
15
Paragraph 10
ASSOCIATION AND DISSOCIATION OF
PARTICIPANTS……………………………………………....
16
Paragraph 11
OTHER MATTERS...........……................................................
17
Annex I
SUGGESTED FINANCIAL CONTRIBUTIONS FOR
VOTING
PARTICIPANTS……………………………………………....
18
Annex II
COOPERATION AGREEMENT………………………………
19
Annex III
REQUEST FOR PROPOSAL TO HOST SECRETARIAT…..
20
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MEMORANDUM OF UNDERSTANDING
FOR THE
GLOBAL BOLOGICAL RESOURCE CENTRE NETWORK (GBRCN)
The signatories to this non-binding Memorandum of Understanding, being countries, economies, or
inter-governmental organisations, or entities designated by countries, economies, or inter-governmental
organisations, have decided that a co-ordinated international scientific-technical effort is needed to
enable academic, industrial and regulatory users throughout the world to discover and put to use the
laboratory based ex-situ global biodiversity held by BRCs and its related data, thereby advancing
scientific research in many disciplines, promoting biotechnological and sustainable development,
facilitating the equitable sharing of the benefits of biodiversity, and enhancing the quality of life of
members of society. The importance of making biodiversity accessible to all countries and individuals
is underscored by various international agreements, especially the Convention on Biological Diversity.
Specifically, GBRCN addresses ex-situ conservation of biodiversity and concentrates on laboratory
held, living, propagatable biological material made available from partner institutions.
Recognising this need, the OECD Committee for Scientific and Technological Policy endorsed the
OECD Best Practice Guidelines for Biological Resource Centres at its 89 th meeting in 26-27 March
2007 in Paris. Recommendation X (ten) of the OECD Best Practice Guidelines for BRCs stated that
OECD member countries, together with partner non-member countries, should take additional steps to
develop a virtual inclusive GBRCN based on all the recommendations therein and a commitment to
work towards quality improvement.
The signatories of this Memorandum of Understanding hereby express their intention to become
Participants of GBRCN as a form of technical and scientific international co-operation.
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Paragraph 1
DEFINITIONS
1.
Biodiversity
The short form for “biological diversity”. This means the variability among living organisms
from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the
ecological complexes of which they are part; this includes genetic diversity, and diversity
within species, between species and of ecosystems.
2.
Biodiversity Data
In the context of this MoU, biodiversity data refers to scientific information, primarily about
biological material represented by species and living strains. At the species level, such data
would include inter alia the scientific names of the species and all of its synonyms; the
common name(s) of the species; and other information about the species, such as a description
of the species, its physiological properties, its genetics, its geographic distribution, its
phylogenetic relationships, its role in the dynamics of ecosystem processes including cases of
invasions, its applications, etc. Strain-level data including samples for molecular analysis (e.g.
molecular data, DNA data, barcodes), would include the scientific name of the species to which
the specimen belongs; information on where, when and by whom the specimen was collected;
where the specimen is currently located; who identified it; the specimen accession number; and
other associated information derived from the specimen (e.g. modes of cultivation, modes of
preservation, photographs, hosts) and any other relevant information.
3.
Participant
A country, economy (e.g. recognised financially independent region), inter-governmental
organisation or international organisation, or an entity designated by a country, economy, intergovernmental organisation or international organisation that has signed this MoU and has
expressed its intention to observe the provisions herein. A Participant may designate an entity to
take part in the governance of GBRCN and to act for the Participant in such matters as the
Participant chooses to delegate to it.
4.
Biological Resource Centre (BRC)
Biological Resource Centres are an essential part of the infrastructure underpinning
biotechnology. They consist of service providers and repositories of the living cells, genomes of
organisms, and information relating to heredity and the functions of biological systems. BRCs
contain collections of culturable organisms (e.g. micro-organisms, plant, animal and human
cells), replicable parts of these (e.g. genomes, plasmids, viruses, cDNAs), viable but not yet
culturable organisms cells and tissues, as well as data bases containing molecular, physiological
and structural information relevant to these collections and related bioinformatics. BRCs must
meet the high standards of quality and expertise demanded by the international community of
scientists and industry for the delivery of biological information and materials. They must
provide access to biological resources on which R&D in the life sciences and the advancement
of biotechnology depends. (OECD, 20071 – a definition based on the one adopted at the 1999
Tokyo workshop on Biological Resource centres where the concept of BRCs as an outgrowth of
conventional pre-genomics ex-situ collections of biological materials was developed)
In summary they are institutions holding and providing laboratory held, living propagatable
biological material and related data.
5.
Cooperating entities
A Participant may designate an entity, or entities (e.g. culture collection, BRC or a network of
these with a legal status) to take part in the networking activities of GBRCN and the practical
work towards the goals set in this MoU. Details of the activities of a cooperating entity within
the remit of GBRCN will be governed by a separate Cooperation Agreement (Annex II).
1 OECD Best Practice Guidelines for Biological Resource Centres (June 2007),
http://www.oecd.org/document/36/0,3343,en_2649_34537_38777060_1_1_1_1,00.html
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Ultimately a system that is open for all BRCs to join will be established that ensures access to
high quality materials and information, presenting a number of options of implementation of
OECD best practice.
Cooperation in the network will be based on a process of compliance proof, that the OECD best
practice is implemented sufficiently to assure authentic high quality materials and information.
A BRC can become a cooperating entity of the GBRCN even if its host country is not a
Participant that is signatory to this MoU.
6.
GBRCN Secretariat Host
The institution, agency or other entity which provides the administrative and logistical support
capabilities for the GBRCN Secretariat and in which the GBRCN Secretariat may be located
and housed.
7.
Biological material
The term ‘Biological material’ as used in this document covers all materials listed in item 4
above and in the Organisation for Economic Co-operation and Development (OECD) definition
of BRCs given.
8.
Authentication
Authentication is the process by which biological materials are re-identified up to a defined
level using appropriate technology to establish a conclusive basis for accepting the material as
genuine. This process is defined in the domain specific best practice guidelines for BRCs.
9.
Governance
The infrastructure of the GBRCN may consist of a Governing Board, Co-ordinating
Secretariat and the cooperating entities (defined above). Members of the Governing Board
would be representatives of the Participants who endorse the GBRCN principles by signing a
Memorandum of Understanding. The Governing Board will guide the GBRCN in its actions
and development. The cooperating entities of the network will be the BRCs who will sign up
to the Cooperation Agreement (Annex II) and comply by implementation of Best Practice and
the principles of the GBRCN. A secretariat will co-ordinate activities and work on behalf of
the cooperating entities.
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Paragraph 2
UNDERSTANDINGS
1.
GBRCN is an open-ended international co-ordinating body set up with the overall aim of
furthering technical and scientific efforts to develop a global cooperation forum of and for
institutions holding and providing laboratory held, living and propagatable biological material
and related data.
2.
The Participants’ involvement in this MoU is subject to the goodwill and appropriation or
allocation of funds by the appropriate governmental authorities and to the applicable laws and
regulations of the Participants.
3.
Nothing in this MoU should be read to contradict the principles of the Convention on
Biological Diversity, and its Cartagena and Nagoya protocols, the Budapest Treaty, the
Biological and Toxin Weapons and other relevant Conventions and regional and national
legislation.
4.
This document is not legally binding and will have no effect as a legal or political precedent.
5.
The Governing Board of GBRCN should strive to reach decisions by consensus whenever
possible.
6.
Cooperating entities must adhere to the Cooperation Agreement requirements (Annex II).
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Paragraph 3
OBJECTIVES
1.
Purpose
The purpose of GBRCN is to promote access to high quality ex-situ biological resources and
associated information within an appropriate legal operational framework. It will develop
activities to add value to, broaden coverage and facilitate biological material use to support the
life sciences. GBRCN will work in close co-operation with established programmes and
organisations that utilise biological material and use biological information resources. The
Participants, working through GBRCN, will establish and support a coordinated and distributed
system that will enable users to access and utilise existing and new ex-situ biodiversity and
related expertise and data.
2.
Goals of GBRCN
It is the intention of the Participants that the GBRCN:
(a)
be distributed, share resources, while encouraging co-operation and coherence;
(b)
be global in scale, though implemented nationally and regionally;
(c)
be accessible by individuals anywhere in the world, offering potential benefits to all,
while being funded primarily by those that have the greatest financial capabilities;
(d)
promote standards and procedures designed to facilitate their adaptation nationally and
regionally;
(e)
serve to disseminate technological capacity by drawing on and making widely available
scientific and technical information; and
(f)
make laboratory held, living biological material available to any scientist interested and
authorized to use it, while fully acknowledging their origin and all value adding
contributions made by gathering and furnishing these materials.
Specifically the GBRCN will offer:
•
•
•
•
•
•
•
•
•
•
3.
A network providing facilitated, legal access to biological resources and information
supporting bioeconomy development
A user interface to develop the services and support needed, be they Governments,
regulatory bodies, research and education or bioindustry
Co-ordinated facilities for maintenance and supply of high quality biological material
Common operations and procedures that deliver best practice and quality improved
value to users
Harmonised mechanisms to implement agreed principles on biosafety, biosecurity
Harmonized mechanisms to implement agreed principles on ownership and management
of IP in compliance with national and international legislation
Common rules for materials and data exchange
A single voice of the collections to facilitate input to international initiatives
A mechanism for capacity building
A shared work programme to address key challenges
Involvement of the Participants
Each Participant should seek to:
(a)
participate actively in the formulation and implementation of the GBRCN Work
Programme;
(b)
promote the sharing of laboratory held, living biological material in GBRCN under
common sets of agreements and standards;
(c)
designate their own entities (BRCs), accessible via GBRCN, that will provide access to
biological material and related data;
(d)
as appropriate, make other investments in biodiversity related infrastructure in support of
GBRCN; and
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(e)
4.
contribute to training and capacity development for promoting global access to
laboratory held, living biological material and related data.
Scope of Activity
Through their participation in the GBRCN Work Programme, the cooperating entities seek to
co-operate and co-ordinate efforts and may carry out some or all of the following activities:
Improving the accessibility, completeness and quality of laboratory held, living biological
material, including:
i. Contributing material and technical resources, within an appropriate and agreed
operational framework;
ii. Developing suitable standards and protocols for quality management in
accessioning, authenticating, maintaining and providing biological materials;
documentation and quality control;
iii. Linking and providing tools for analysing new and existing databases; under due
consideration of existing relevant national, regional and global bio-legislation;
iv. Improving coverage and adding value to holdings;
v. Improving access to expertise and capacity building;
vi. Collaborative research programmes; and
vii. Providing collaborative solutions to user requests and focussed activities to
address global challenges.
Co-operation and Co-ordination
The Participants intend to encourage co-operation amongst themselves in the implementation of
GBRCN and in the development of joint work programmes in areas of mutual interest with the
Secretariat of the Convention on Biological Diversity, World Health Organisation, International
Air Transport Association, and other appropriate bodies to avoid duplication and to benefit
from existing resources and expertise.
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Paragraph 4
THE GOVERNING BOARD
1.
Role and Purpose
The Governing Board will be the means by which the Participants will make collective decisions
on all matters relating to the GBRCN Governance and operational scope; detailed action plans will
be developed in agreement with the cooperating entities and implementation co-ordinated by the
GBRCN Secretariat.
2.
Establishment
The Governing Board will come into existence at the first meeting of the Participants after
establishment of GBRCN, subject to the provisions of Paragraph 11.
3.
Composition
The Governing Board will consist of one representative from each Participant. There are two
modes of participation:
(a)
Voting Participants
Participants that decide to make the financial contribution suggested in Annex I, or, in the
case of an economy, inter-governmental organisation or other organisation, the financial
contribution negotiated under the provisions of Paragraphs 6.5c and 10.2, may vote on the
Governing Board, following the procedures indicated in Paragraph 4.5.
(b)
Associate Participants
Participants that have not yet decided to make a financial contribution as suggested in
Annex I may take part in the deliberations of the Governing Board, but may not vote.
4.
Additional Participants
The Secretariat of the Convention on Biological Diversity, and other global organisations of
relevance such as the BTWC and the WHO, will be invited to designate a non-voting
representative to the Governing Board.
5.
Voting
(a)
Unless otherwise indicated, the provisions of this Paragraph apply only to Voting
Participants pursuant to Paragraph 4.3(a).
(b)
The Governing Board should strive to work by consensus whenever possible. Except
where mandated that a decision must be made by consensus, if consensus cannot be
reached after reasonable attempts have been made, then approval by super-majority of
those present and voting is required.
(c)
A super-majority vote is the affirmative vote of a two-thirds majority of the Participants
present and voting.
(d)
In all cases in which this MoU expressly provides that the Governing Board act by
means of a consensus decision or a vote of the Participants present and voting, “present”
can mean face-to-face, by telephone, video conference, or other practical means
determined in advance by the Governing Board.
The Governing Board, acting by consensus, and if consensus cannot be reached, by super-majority
vote, may also offer voting or non-voting participation for such period as the Governing Board
deems appropriate to any economy, inter-governmental organisation or other organisation.
6.
Responsibilities
The Governing Board may:
(a)
(i) Establish rules of procedure
(ii) Form partnerships
(iii) Adopt a strategic plan
(iv) Monitor the strategic plan
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7.
(b)
select a GBRCN Secretariat Host with reference to the criteria established to solicit
bids for the GBRCN Secretariat Host (Annex III);
(c)
adopt a Work Programme and Budget;
(d)
adjust, by consensus, the scales of financial contributions suggested in Annex I, using
appropriate economic indicators such as GDP;
(e)
adopt such rules, regulations and policies as may be required for the sound
management of the Work Programme, while assuring adherence to the provisions of
Paragraph 9 and any financial rules established by the Governing Board;
(f)
allocate some of the funds provided in the Budget to implement the Work
Programme, consistent with the regulations and decisions of the Governing Board;
(g)
monitor the performance of the GBRCN Secretariat Host; if necessary, the Governing
Board may replace the GBRCN Secretariat Host;
(h)
select a General Manager / Executive Secretary; the Governing Board may also
remove the General Manager / Executive Secretary;
(i)
approve the staffing level and staffing plan for the GBRCN Secretariat based on
recommendations from the General Manager / Executive Secretary;
(j)
provide guidance and direction to the General Manager / Executive Secretary on the
duties of the position and monitor the General Manager's / Executive Secretary’s
performance;
(k)
carry out the other functions conferred upon it by this MoU, including by any
Annexes or modifications hereto;
(l)
consider any matters pertaining to GBRCN or its operations submitted to it by the
General Manager / Executive Secretary, the GBRCN Secretariat Host, or by any
Participant; and
(m)
consider at each meeting any outstanding applications by any Government seeking to
sign the MoU, as well as any outstanding applications by any economy, intergovernmental organisation, or other organisation seeking to become a Voting
Participant, in accordance with Paragraph 4.5.
Executive Committee
The Governing Board may establish an Executive Committee that is responsible for monitoring
the performance of the Secretariat in implementing the decisions of the Governing Board,
including the Strategic Plan, the Work Programmes, and budgets, and for making those
intersessional decisions delegated to it by the Governing Board.
8.
Procedures
The Governing Board may establish such subsidiary bodies and rules of procedure as are required
for its proper functioning.
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Paragraph 5
THE GBRCN SECRETARIAT HOST (See ANNEX III)
1.
Role and Purpose
The GBRCN Secretariat Host will provide the location, facilities and services agreed to in an
arrangement between the Governing Board and the GBRCN Secretariat Host. The services may
cover staff management, financial management, accountancy, legal assistance, etc. The GBRCN
Secretariat Host may house the GBRCN Secretariat and manage it in accordance with the laws in
force in the country of the Host. The GBRCN Secretariat Host will also obtain or provide legal
status for the GBRCN Secretariat.
2.
3.
Selection
(a)
The GBRCN Secretariat Host will be chosen via a competitive bidding process
(b)
Any Voting Participant is entitled to submit a bid for the GBRCN Secretariat Host
(c)
The bidders for the GBRCN Secretariat Host will be required to demonstrate their
capacity to provide institutional arrangements that conform to the closest extent possible,
under their respective domestic laws, with the criteria for the GBRCN Secretariat Host,
GBRCN Secretariat and General Manager / Executive Secretary, as outlined in this MoU
and in the Request for Proposal to Host the GBRCN Secretariat, and that satisfy any
other criteria required by the Governing Board.
Scope of Authority
Subject to the laws of the jurisdiction in which the GBRCN Secretariat Host is located:
4.
(a)
The GBRCN Secretariat Host will be accountable to the Governing Board for all matters
pertaining to the GBRCN Secretariat, except as otherwise provided in this MoU;
(b)
The GBRCN Secretariat Host will either house the GBRCN Secretariat and engage the
General Manager or Executive Secretary and other GBRCN staff as directed by the
Governing Board, or will facilitate such housing and engagement (paragraphs 6.5 and
6.6).
GBRCN Secretariat/GBRCN Host Relationship
The GBRCN Secretariat Host should assist the GBRCN Secretariat to implement the Governing
Board decisions.
5.
Reimbursement of Costs
Through appropriate financial arrangements with the GBRCN Secretariat, expenses and costs
reasonably and properly incurred by the GBRCN Secretariat Host in supporting the GBRCN
Secretariat, above those costs that the GBRCN Secretariat Host itself has agreed to provide, may
be paid from the funds collected pursuant to Paragraph 9. Neither the GBRCN Secretariat Host,
nor its experts, employees, agents, representatives or contractors are entitled to commit the
Participants to any expenditure beyond what is available in the Central Fund, as defined in
Paragraph 9.1.
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Paragraph 6
THE GBRCN SECRETARIAT
1.
Designation
The GBRCN Secretariat will consist of the Managing Director or Executive Secretary and such
staff as are judged necessary by the Governing Board to implement the Work Programme.
2.
Legal Status
The GBRCN Secretariat Host is responsible for ensuring that the GBRCN Secretariat is accorded
a legal personality in the Host country, in order that it can, for example, make contracts, and
acquire and dispose of movable property.
3.
Accountability
The GBRCN Secretariat will be responsible through the General Manager or Executive Secretary
to the Governing Board for the execution of all scientific and administrative activities undertaken
to implement the GBRCN Work Programme. The activities of the GBRCN Secretariat will be
subject to the laws and jurisdictions in force in the country of the GBRCN Secretariat Host.
4.
Responsibility
The GBRCN Secretariat will execute the Work Programme and expenditure of the budget, under
the direction of the General Manager or Executive Secretary.
5.
Tasks
The GBRCN Secretariat will:
6.
(a)
be the holder of the Central Fund described in Paragraph 9.1;
(b)
be responsible for developing financial contracts with Voting Participants specifying how
those Participants will make their financial contributions to the Central Fund; and
(c)
hold in trust, and for the benefit of the Participants, all assets which may accrue to or be
acquired for GBRCN.
Transfer of Tasks to the Secretariat Host
Through appropriate financial arrangements between the Secretariat Host and the Secretariat, and
with the approval of the Governing Board, some or all of the tasks listed in Paragraph 6.5 may be
transferred to the GBIF Secretariat Host.
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Paragraph 7
THE GENERAL MANAGER or EXECUTIVE SECRETARY
1.
Authority
The General Manager or Executive Secretary will act as the chief executive officer of GBRCN
and will have the authority, within limits and guidelines decided by the Governing Board, and,
subject to the provisions of this Memorandum of Understanding, to enter into contracts and
administer funds on behalf of GBRCN. The activities of the General Manager / Executive
Secretary will be subject to the laws and jurisdictions in force in the country of the GBRCN
Secretariat Host.
2.
Accountability
The General Manager or Executive Secretary will be responsible to the Governing Board for the
execution of all scientific and administrative activities of the GBRCN Secretariat. The duties of
the office will be specified in the engagement contract of the General Manager or Executive
Secretary.
3.
Responsibilities
The responsibilities of the General Manager or Executive Secretary are to:
(a)
Oversee the execution of the Work Programme and expenditure of the Budget;
(b)
Recommend to the Governing Board the hiring of such staff as may be required to carry
out the Work Programme;
(c)
Supervise the work of the GBRCN Secretariat and its staff, including consultants and
seconded personnel;
(d)
Prepare and submit to the Governing Board, not later than three months before the
beginning of each financial year, a draft annual Work Programme and a Budget, together
with an indicative Draft Work Programme and a Draft Budget for the following two
years; and
(e)
Provide the Governing Board with a technically substantive annual report on the Work
Programme, including financial accounts, tasks achieved, tasks not achieved and any
appropriate explanations.
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Paragraph 8
INTELLECTUAL PROPERTY
1.
Applicable Law
Nothing in this MoU should be read to alter the scope and application of Intellectual Property
Rights and benefit sharing agreements as determined under relevant laws, regulations and
international agreements of the Participants.
2.
Access to Biological Material and Related Data
To the greatest extent possible, GBRCN is fostering facilitated access to holdings at BRCs within
an appropriate legal operational framework. All users, whether GBRCN Participants or others,
ought to have equal access to biological material and data in BRCs affiliated with GBRCN.
Material Transfer Agreement should regulate supply and exchange of materials, communicating
terms and conditions of access and use. Model texts are available, see the ECCO Core MTA text
(http://www.eccosite.org).
3.
Intellectual Property Rights
GBRCN encourages exchange of ex-situ biological material in compliance with national law and
international conventions.
To clarify the rights and obligations of the GBRCN cooperating entities with respect to joint
activities:
The GBRCN works together for the benefit of its cooperating entities.
IPR belongs to the individual cooperating entity creating the IP. The GBRCN will only benefit
where the activity benefits from the input or association with the GBRCN, and the income accrued
from the benefit will be used to further develop the GBRCN.
It is the intention that policies and new products are developed jointly by the interested GBRCN
cooperating entities that can contribute. IPR issues will be agreed in writing as necessary in each
specific case.
In respect to products or processes and use claims developed jointly within the GBRCN, sharing
of benefits resulting from the marketing of the product will be defined in a specific agreement.
4.
Attribution
GBRCN should seek to ensure that the source/origin of biological material and data is
acknowledged and should request that such attribution be maintained in any subsequent passing
on and use of the material and data.
5.
Authenticity of Biological Material and Validity of Data
It should be a condition of access to and use of GBRCN that users acknowledge that the
authenticity of biological material in affiliated BRCs and the validity of the data in any databases
affiliated with GBRCN cannot be assured by GBRCN. GBRCN should disclaim responsibility for
the accuracy and reliability of the biological material and data as well as for the suitability of its
application for any particular purpose.
6.
Legitimacy of Acquiring Biological Material
Where a cooperating entity adds new biodiversity resources and associated information to its
holdings, GBRCN should require that such access was consistent with applicable laws, regulations
and any relevant requirements related to access and benefit sharing (ABS).
7.
Technology Transfer
The Participants acknowledge that, subject to any relevant Intellectual Property Rights, GBRCN
should seek to promote the non-exclusive transfer to research institutions in countries of
developing economies of technology as it has available, especially in conjunction with training
and capacity development programs.
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Paragraph 9
FINANCE
1.
Basic Financial Contributions
Financial contributions made by Participants in accordance with the scales set out in Annex I (and
transferred to the GBRCN Secretariat via the financial contracts described in Paragraph 6.5(c)), or
negotiated with the Governing Board under the provisions in Paragraph 4.6(d), are considered to
be Basic Financial Contributions. These contributions are to be held by the GBRCN Secretariat in
a Central Fund and used to fund the Work Programme, as established by the Governing Board in
accordance with Paragraph 4.6(c), and to reimburse the GBRCN Secretariat Host for expenses
incurred in accordance with Paragraph 5.5.
2.
Supplementary Financial Contributions
In addition to Basic Financial Contributions, Participants may make Supplementary Financial
Contributions to fund specific parts of the Work Programme, or for other specified purposes
agreed to by the Governing Board. Those specified purposes may include facilitating attendance
by Participants from countries of developing economies at meetings of the Governing Board.
Supplementary Financial Contributions are to be held by the GBRCN Secretariat, kept separate
from basic and other contributions, and used only for the purposes specified by the Participants
making them.
3.
Other Income
The Governing Board may accept other income offered for the purposes set out in this MoU which
will be held by the GBRCN Secretariat.
4.
Costs Borne by Participants
Participants bear the costs of their own participation in GBRCN, including the costs of
formulating or transmitting reports, travel costs, and other expenses related to attendance by their
representatives at meetings of the Governing Board and other GBRCN functions, events, and
activities.
5.
Crediting of Income
Any income generated in the course of GBRCN activities that accrue to the GBRCN Secretariat or
the GBRCN Secretariat Host is to be used to fund the Work Programme, as established by the
Governing Board in accordance with Paragraph 4.6(c), and to reimburse the GBRCN Secretariat
Host for expenses incurred in accordance with Paragraph 5.5.
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Paragraph 10
ASSOCIATION AND DISSOCIATION OF PARTICIPANTS
1.
Association of Participants
Association with this MoU is open to any country, economy, inter-governmental or international
organisation or to an entity designated by them. Such association becomes effective upon signing
this MoU.
2.
Participant Status
(a) A country, economy, inter-governmental or international organisation that has signed the MoU
becomes eligible to be a Voting Participant on the Governing Board by making the financial
arrangement negotiated with the GBRCN Secretariat, as described in Paragraph 6.5(c). This
arrangement sets out the Voting Participant’s financial contribution as suggested in Annex I,
and the period for which the arrangement is valid.
(b) In order to retain its voting status, a Voting Participant must make its financial contribution
each year within six months of the due date set out in the financial arrangement described in
Paragraph 6.5(c).
3.
Dissociation of Participants
(a) Any Participant may dissociate itself from this MoU by advising the Governing Board in
writing of its intention to do so and of the effective date.
(b) In the event of dissociation of a Voting Participant, the Governing Board may decide by
consensus to adjust the Work Programme and the Budget to take account of such dissociation
or, again by consensus, may decide to adjust the scale of contributions of Participants to the
Budget.
4. Cooperating entity status in the event of Dissociation of Participant (country, economy, intergovernmental or international organisation)
The cooperating entity can remain affiliated regardless of whether the country where it is situated
is a participant or not.
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Paragraph 11
OTHER MATTERS
1.
Establishment of GBRCN
GBRCN will come into existence on (MONTH) xx, 20xx, or when at least ten Participants have
signed the MoU and the sum of the contributions they have pledged to contribute totals at least
500K EURO2, whichever is the later date.
2.
Duration
Except as provided below, GBRCN will be set up for an initial 5-year period. In the third year, an
independent review of its operations, financial mechanisms, legal basis, governance structure, and
links to other organisations will be conducted to determine if any changes are needed. The lessons
learned will be used to evaluate the effectiveness of the governance structure and to recommend
any necessary changes.
3.
Termination
The Voting Participants, acting by consensus, may terminate this MoU at any time. Upon
termination or expiration of this MoU, the GBRCN Secretariat, acting in accordance with the laws
of the jurisdiction in which it is located, will arrange for the liquidation of the assets of GBRCN.
Property held by the GBRCN Secretariat for the benefit of the Participants, is to be regarded for
this purpose, as assets of GBRCN. In the event of such liquidation, the GBRCN Secretariat, so far
as practicable, will distribute any assets of GBRCN, or the proceeds therefrom, in proportion to
the basic financial contributions which the Participants have made from the beginning of the
operation of GBRCN, and for that purpose will take into account the contributions of any former
Participants.
3.
Annexes
Annexes to this MoU are an integral part of the document but can be modified independently
subject to approval of the Governing Board.
4.
Modifications
Except where otherwise specified, this MoU and any Annexes thereof may be modified at any
time by the Governing Board.
Signed at ________________ this _____ day of ______________, 20__.
2 This figure reflects a first estimate on running costs of the secretariat and would need revisiting when the envisaged structure’s
costs can be more accurately defined and agreed
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Annex I
FINANCIAL CONTRIBUTIONS FOR VOTING PARTICIPANTS
1.
Intent of this Annex
This Annex describes the suggested financial contributions for voting participation in GBRCN.
2.
Suggested Basic Financial Contributions
Voting rights are conferred when a Participant indicates its intention to contribute the suggested
amount according to the Table below.
3.
Initial Year Payment
For the first year of their participation in GBRCN, Participants in categories 1-6 inclusive in the
Table below may acquire voting rights by making a contribution of at least one half of the
suggested amount according to the Table below.
Participant Categories and GDPs
Suggested Annual
Basic Financial Contribution
Participant (voting)
1—GDP > $3000 billion
€180 000
2—GDP $2000-3000 billion
€100 000
3—GDP $€1000-2000 billion
€80 000
4—GDP $100-1000 billion
€30 000
5—GDP $50-100 billion
€5 000
6—GDP < $50 billion
€2000
Associate Participant (non-voting)
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Annex II
GBRCN COOPERATION AGREEMENT (GBRCN DOCUMENT GP-WP-0010)
The Cooperation Agreement is made with the objective of further increasing collaboration and cooperation between the Cooperating Entities of the GBRCN. The GBRCN Cooperating Agreement is
to be signed by each GBRCN Cooperating Entity and strictly followed. Failure to do so may result in
dissociation from the GBRCN.
1.
The fundamental principle
The GBRCN gives access to authentic high quality materials in a reproducible manner and that the
OECD Best Practice Guidelines for BRCs (OECD BPG) are implemented.
The GBRCN is open for all BRCs to join but it must ensure access to high quality materials and
information, they will be differentiated on to the extent to which they implement OECD BPG and their
level of expertise and thus input to the GBRCN operations. They may be differentiated as:
Candidate or associate entity that has begun the process of implementing best practice and has
an agreed and funded plan of action to implement the minimum level of best practice
Basic level BRC - a BRC that has implemented the agreed minimum level for delivery of:
Authentic material
Best Practice in preservation
Confirmed, validated information
Certified BRC that has adopted a certification process such as ISO 9001 or the French AFNOR
standard NF 596-900
Accredited BRC that has been accredited to a standard that covers not only management
practices but also extends to assess the competence to perform the necessary functions of a
BRC
A transparent mechanism will be devised to enable the user to distinguish the BRCs at the different
levels of development and input to the GBRCN. BRCs may have different scopes and expertise and
will contribute to the GBRCN delivery in different ways accordingly. Participation in the network is
not based on a BRC becoming certified or accredited, this is their choice but a mechanism to ensure
authentic high quality materials and information is needed. Participation does not require the OECD
Best Practice Guidance for BRCs to be implemented in full and therefore cooperation in the GBRCN is
based upon a gradual implementation of excellence. A minimum level of implementation will be set
and independent assessment mechanisms will be available to be managed by accreditation and
certification bodies.
2.
Cooperating Entity commitments
BRC status is assigned to those biological resource collections that implement OECD best practice (as
described above) and that participate in the Global Biological Resource Centre Network (GBRCN)
meeting the Cooperating Entity Commitments. Host Countries of BRCs may select the appropriate
process for third party independent assessment of compliance with OECD Best Practice Guidance for
BRCs. Accepted practices are provided in GBRCN approved documentation to ensure
complementarity and equivalence of the implementation process internationally.
3.
BRC mandatory guidance
The BRCs shall comply with:
• Their national legislation, regulations and policies concerning acquisition, conservation,
utilisation, including the fair and equitable sharing of benefits arising from utilisation of
genetic resources, and distribution of biological resources and data related thereto
• The regulations of the relevant countries when moving biological materials across national
boundaries.
• The relevant international agreements. Legislation, policy, frameworks and recommendations
4.
Key objectives of the GBRCN which cooperating entities agree to help deliver:
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•
•
•
•
•
•
5.
A single point of contact for participating BRCs
Establishment of an electronic information resource
A co-ordinated development strategy
Implementation of a common Quality Management System
Common policies and mechanisms for compliance with national and international legislation,
regulations and policies impacting on BRC operations
Collaborative research to enhance expertise and data according to each BRC’s capabilities
Principles of adherence for the BRC:
The first criterion is implementation of best practice as described above but to ensure that the user
receives the high quality materials and a legitimate service the following commitments are required.
The BRC shall:
i.
Provide access to their biological holdings
ii.
Use transparent mechanisms in the exchange of biological materials to facilitate tracking
iii.
Co-operate to broaden access to holdings of unique and well-characterised organisms
iv.
Provide linkage to at least to the minimum level of data pertaining to their holdings
v.
Follow the commonly agreed GBRCN operational frameworks
vi.
Implement the requirements of the Nagoya protocol
vii.
Implement Biosafety and Biosecurity guidance and the Biosecurity code of conduct3
viii.
Protect existing Intellectual Property Rights
ix.
Adhere to an appropriate Confidentiality and IPR statement
x.
Participate in joint research activities subject to ability and funding
xi.
Engage in exchange visits of scientists subject to mutual benefits and available funding
xii.
Participate in appropriate capacity building subject to available resources
3The Biosecurity code of conduct negotiated by the GBRCN and EMbaRC consortia submitted to the UN BTWC (Reference to
be inserted when published)
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Annex III
REQUEST FOR PROPOSALS TO HOST THE SECRETARIAT
This Annex describes the requirements and procedures to be followed for submitting a bid to host the
Global Biological Resource Centre Network (GBRCN) Secretariat4.
1.
Role and purpose
The GBRCN Secretariat Host is to provide the location, facilities and services agreed to in an
arrangement between it and the GBRCN (Acting) Governing Board. Expected services include, but are
not limited to, staff management, financial management, accountancy, legal services, Internet access,
IT capabilities, and logistical & technical assistance. The GBRCN Secretariat Host is to house the
GBRCN Secretariat and manage it in accordance with domestic laws. The GBRCN Secretariat Host is
to also obtain or provide legal status for GBRCN. Subject to the laws of the country in which it is
located, the Secretariat Host will be accountable to the Governing Board for all matters pertaining to
GBRCN.
2.
Eligibility
A bid may be submitted on behalf of a government or an institution that intends to be a Participant or
Cooperating Entity of the GBRCN.
3.
Required contents of a bid
Proposals must include the following information:
A. Background: A description of the proposed host organization, including its location, physical and
managerial capabilities and its appropriate research significance and related resources.
B. Plan: An analysis of how the proposed Secretariat Host is to meet the requirements of this
solicitation and the requirements of the GBRCN MoU:

Legal Status of GBRCN. The bid should describe the proposed legal status of GBRCN, which
should allow it to carry out the activities and work programme under the orders and authority of
the Governing Board. GBRCN should be able to receive and disburse funds, enter into contracts
for goods and services, hold title to property, and hire personnel as needed. This status should
preferably be similar to that of a non-profit organization with tax-free status consistent with the
laws of the country. The bid should describe the benefit, if any, that GBRCN could derive from
special rules or exemptions (for instance, on taxes or import duties), and the degree of
legal/administrative independence for GBRCN. It should also include a description of any local
regulations that could impose restrictions on GBRCN, its funding, or operation. A detailed
description of the organizational relationship between GBRCN Secretariat and the host
organization.

The Secretariat Host. The bid should identify a legal entity in the host country that will be
closely associated with GBRCN and, as specified in a legal agreement with GBRCN, may provide
certain facilities, infrastructure and services needed to carry out its activities. It should provide an
explanation of how the host organization can accommodate the needs of the GBRCN Secretariat
and which of the required capabilities, if any, is to be outsourced. The date/time frame for the
availability of the infrastructures/resources and legal status should be provided. The initial contract
for the Secretariat Host will be for a period of five years and subject to evaluation every 3 years in
the GBRCN full evaluation process. Following that period, if agreed by the GBRCN Governing
Board and the Secretariat Host, the contract may be extended for additional periods. Either party
may, without cause, terminate this arrangement by providing six months written notice to the other
party.

GBRCN Secretariat Staff: The bid should specify the engagement status of the staff, including
rights, benefits and pension rights (if any). Provision should be made for hiring staff of any
nationality. The personnel management provisions (hiring, review, termination, etc.) should be
described. The potential engagement status of staff companions should be specified. The bid
4This is example text adapted from SciColl – Science Collections International text and is only provided as guidance on which
to base the eventual GBRCN process
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should describe the status of GBRCN officers and professional staff, technical and support staff
and staff companions. The bid should also describe any special provisions for staff co-located
with GBRCN but seconded from and paid by another institution or country. It should include a
description of personnel management provisions (hiring, review, termination, etc.)

Receiving funds: The bid should describe the process for receiving, holding, managing and
accounting for funds from contributing countries, public or private institutions, private company
sponsors, and other entities. The process for receiving in-kind contributions should also be
specified. Plans for management and accounting of GBRCN’s finances, including a plan of how to
manage currency fluctuations and possibly cash flow delays between expenditures and income
should be included.

Disbursing funds: The bid should specify how goods and services will be purchased at the
request of GBRCN under the authority of the Governing Board or it’s designate. It should
describe efficient procedures that will allow GBRCN to use its funds to pay for certain expenses,
including the following:

o
General Manager/Executive Secretary: Salary and benefits
o
Staff: Salaries and benefits for staff personnel,
o
Consultants for services including, but not limited to legal and intellectual property rights
o
Travel
o
Expenses incurred by members of the GBRCN Executive board, members of the GBRCN
Scientific Advisory Board, members of GBRCN task groups or others as agreed by
Governing Board
o
Workshops, meetings, training, and technology transfer
o
Purchase and maintenance of specialized equipment or software,
o
Other costs related to GBRCN operations, as approved by the GBRCN Governing Board or
its designate
Office space and meeting facilities: The bid should describe details of the space being offered
and its availability, as well as additional services provided by the host for GBRCN Secretariat,
taking into account a requirement for 3-8 staff.
C. Budget: Provide an analysis of any funds that the submitting country/institution is offering to
commit to the Secretariat, and assurance that these funds are in fact available.
Voluntary Contributions of the Bidding Country/Institution: Each bidding country or institution is
encouraged to contribute optional goods and services to GBRCN, both at GBRCN start-up, and on an
ongoing operational basis. Such contributions may include those listed below. This list is meant to
provide examples, but not be exhaustive. Each bid should include any relevant items that may not be
listed but are deemed valuable by the bidding Host. Each bid should also specify the availability and
cost, if any, of the contributions listed below, as well as any other relevant contributions:

Space and furnishings ─ including offices and general work areas to support an appropriate and
potentially flexible number of Secretariat staff, classroom/conference space, space for visiting
scientists and students, off-site temporary housing for visiting scientists and students. As a frame
of reference, number of permanent staff anticipated is about 3-8

Financial contributions to GBRCN above and beyond the Institution or Government Contributions
outlined in the GBRCN MoU

Seconded staff position (technical or administrative), full or part-time, to GBRCN Secretariat, to
work under the supervision of the General Manager or Executive Secretary

Utilities, including lighting, electricity, cooling, and heating

Communications infrastructure

Computing infrastructure

Office equipment
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
General facilities infrastructure, including housekeeping services, signage, parking for staff and
visitors, postal services, storage, and security

Financial services, including general accounting, payroll, inventory, purchasing, audit, tax
compliance, and legal compliance

Donations and grants management

Clerical staff

Computing and communications infrastructure services ─ including ISP and LAN maintenance

Contracting services, including the ability to make, accept, and manage contracts with third
parties.

Human Resource Management

Legal services, including but not limited to services for confidentiality, liability, and protection of
intellectual property

Recruitment and hiring, including the ability to hire non-nationals on a non-discriminatory basis.

Benefits, including health insurance, a convertible retirement program, sick leave, vacation leave,
education and childcare, etc.

Equal-opportunity recruitment policy

Non-discrimination engagement policy
D.
Desirable Attributes
Additional desirable attributes of a bid could include items listed below. Again, this list is not meant to
be exhaustive, and the bidding Host should include all items deemed valuable, even if they are not
listed.

Placement of the Secretariat within, or with easy access to, a relevant research collection
organisation

Proximity and ready availability of information technology, including a robust library and open
access to on-line journals

Proximity or easy access to other international organizations with whom GBRCN might need to
coordinate

Proximity to an international airport and convenient local ground transportation

Meeting facilities

Access to language/cultural orientation classes for Secretariat staff and families, work permit for
staff companions

Access to convention planning/hosting capabilities

Non-smoking workplace
4.
Criteria for evaluation and selection of secretariat host
The Secretariat Host is to be chosen by the Governing Board, as defined in the GBRCN MoU, or the
Acting Governing Board at the time (defined below). The bidders for the GBRCN Secretariat Host are
required to demonstrate their capacity to provide for institutional arrangements which conform to the
closest extent possible, under their respective domestic law, with the criteria for the GBRCN
Secretariat Host, GBRCN Secretariat and General Manager or Executive Secretary, as outlined in the
GBRCN MoU and in the Request For Proposals (RFP) To Host The GBRCN Secretariat, and which
satisfy any other criteria required by the Governing Board.
Acting Governing Board: Prior to the establishment of GBRCN as a legal entity, the Acting
Governing Board will consist of one delegate from each country and institution having provided
evidence of the intent to become a Participant; Governments from such countries and Institutions are
invited to send a letter of intent to RESPONSIBLE ENTITY TO BE DECIDED by date
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Criteria for the selection of the Secretariat Host include, but are not limited to, the following:
 The Proposal itself as an example of the Bidder’s work (such as the details or completeness in
responding to all aspects of the RFP)
 The Bidder’s organizational and institutional ability to provide the services listed in this RFP
 The extent to which to Bidder can host GBRCN as an independent legal / administrative entity
with purchasing and contracting autonomy
 The additional amenities offered by the Bidder
 The financial support and incentives, including but not limited to tax-exempt status and cost of
host-provided services, offered by the Bidder
 Proximity and ready availability of information technology
 The Bidder’s technical approach and project organization, as presented in response to this RFP
 The experience of the Bidder in hosting other international programs
5.
Procedure for submitting a bid
Questions about bids, procedures, selection criteria, or any other related item are welcome in advance
of submitting a bid. The questions, and their responses, will be posted to the GBRCN home page in a
timely fashion. Therefore it is strongly encouraged to check the GBRCN website frequently for
updates before submitting a bid.
Bids should be provided, both in digital form and on paper and the bidder will be notified when the
materials have been received. PROCESS AND RESPONSIBLE ENTITY TO BE DECIDED
6.
Procedure for the review of proposals
An international committee of three to four members will be selected comprised of experts in the areas
of research collection management, use of research collections and representing appropriate
professional organizations or science administration. These individuals will be capable of providing
neutral evaluations.
The proposals are to be sent to the committee at least two weeks prior to their meeting to review the
applications. At the review meeting each application is to be discussed by the reviewers and evaluated
using the criteria outlined in this document. A brief critique written jointly is to be provided for each
proposal delineating the strengths and weaknesses. Criteria which can be directly compared among all
bids will be evaluated on a comparative (ranked) basis. Additional criteria, which may not be
provided in all bids, will be considered separately on a case-by-case basis. The committee will rank
the proposals. Within one month following the postmark deadline, the committee will send to the
(Acting) Governing Board copies of the proposals, a document that justifies the rankings, and the brief
critiques of all of the proposals. PROCESS AND RESPONSIBLE ENTITY TO BE DECIDED
7. Procedure for selecting the secretariat host
The (Acting) Governing Board is to receive copies of the ranked proposals as well as the reviews from
the review committee. The (Acting) Governing Board will meet physically or virtually within three
weeks of receipt of the materials from the review committee, and will select the host based on this
material.
The (Acting) Governing Board should make its final decision by date
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GBRCN Architecture, rationale and operation
Introduction
The components and infrastructure of the GBRCN Secretariat are defined in the GBRCN
Memorandum of Understanding (GBRCN document GP-PM-0008). This GBRCN
Architecture, rationale and operation document provides further information on the GBRCN
structure and its operations. Applying common standards for operations to deliver access to
high quality materials is a key objective of the GBRCN and therefore a need to take full
advantage of cross network expertise and facilities. The scope is broad: it must be ensured
that biodiversity is captured, maintained and utilised requiring sharing of expertise and
technologies. The big issues of climate change, synthetic chemistry, biotechnology industry
development, advances in the life sciences clearlyimply the need to harness biological
capacity to address issues of food, energy, health and poverty are clear. The GBRCN will
provide an environment to address such key issues. It will be an engine of innovation and
burden sharing for efficiency and delivering innovative solutions – the GBRCN architecture
is designed to facilitate such processes.
There were several options considered for GBRCN architecture by the OECD Biological
Resource Centre (BRC) Task Force and subsequently in the execution of the GBRCN
Demonstartion Project work. Ultimately the nature of the GBRCN, its need to relate closely
to policy makers to enable it to remain close to user needs, whilst consisting of the biological
resource centres themselves to provide resources for research in a co-ordinated way,
necessitates Government participation and co-ordinated policy. An existing model that offers
a proven way forward is GBIF. The guidance and commitment of countries is essential if
materials and information are to flow across borders to underpin research into the global
challenges.
In the GBRCN model, Governments of interested countries will sign up to the GBRCN
Memorandum of Understanding (GBRCN document GP-PM-0008) as Participants who will
guide the GBRCN in its deliverance of its key function and help ensure facilitating policy.
They will form a Governing Board which will represent the Participants in the GBRCN
Governance and who will be responsible for selection of host country for the Secretariat. The
GBRCN Secretariat will be responsible for:
 Coordinating the common approaches for BRCs
 Managing the global network of national BRCs
 Coordinating the BRC initiative with other international initiatives
 Providing an intergovernmental forum on BRC issues
 Project development and management
 Outreach and publicity
 Organisation and delivery of capacity building programmes
It is essential for any network that participating entities employ similar practices and deliver a
common front to their users. The OECD BRC Best Practice sets a baseline for operations
and there may well be several approaches to deliver the desired final implementation
mechanism. However, there are several areas where harmonised approaches are desirable to
avoid confusion and to set minimum levels of operation where regulations or guidance are
not available. For example, compliance with various international conventions can be
problematic when they are not always applied universally or interpreted differently and
implemented to different extents nationally. It will be interesting to see what can be done in
this regard. It is difficult to see how BRCs can have one approach to compliance with the
Convention on Biological Diversity if nations implement, for example, the requirements of
the Nagoya Protocol in different ways. To help coordinated implementation of the Protocol,
the GBRCN can put in place best practice that enables tracking of biological materials and
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transparency in the terms and conditions for access and use. In other areas of legislation,
common approaches to implement agreed principles on biosafety, biosecurity, ownership and
management of IP enforced by existing national, regional and global legislation can be
explored. It is essential that the GBRCN does not work in isolation and therefore it needs to
work closely with policy makers and international organisations such as the CBD Secretariat,
WHO and WIPO.
The GBRCN will be established as a legal entity in law but the complicating issue is that
participation is global with each country recognising its own national law. Initially the
Secretariat will be hosted in a country and be subject to the law of that country. If GBRCN
activities are to be co-ordinated and operated in compliance within one legal framework some
policy decisions are needed. Ultimately national law governs activities of any BRC and all
the network can do is to agree guiding principles. Where specific pieces of law do not exist,
agreed principles of operation can be written into the Cooperation Agreement (GBRCN MoU
Annex II) so long as they do not contravene national law. Such principles must be accepted
by the GBRCN Cooperating Entities and recognised by their Governments. The underlying
principles for the GBRCN are common policies on access, use and distribution of genetic
materials yet many countries still need to implement the Convention on Biological Diversity
principles effectively. The increasing move of biotechnology to harness the potential of
biodiversity gives ex-situ collections, BRCs, a role to play, but for a Global Biological
Resource Centre Network to work, each nation needs a clear policy on the ex-situ
conservation and utilisation of genetic resources.
Why does the GBRCN need a Secretariat? Most culture collection networks operate on a
volunteer basis and rely on personal commitments to take forward actions. This will not
work for the GBRCN. A small Secretariat should be established consisting of a restricted
number of key staff that could include a Director, Operations manager or Executive secretary,
IT support, a Quality manager and an Administrator/secretary. Costs for such need first of all
to be met by grant in aid with the ultimate goal to find a more sustainable method of finance
(see GBRCN MoU GP-WP-0008). Some of the deliverables could be associated with
securing funding as stand alone projects. The Secretariat would manage delivery from some
of these projects or would be responsible for work packages or a conduit for information and
development. It is important that the Secretariat has access to IT support and quality
management consultancy to enable to carry out the key functions of managing the network
information system and the quality management system implementation and development.
The Secretariat would be responsible to a Governing Board for the running of the network
and delivering an agreed programme of work. A host organisation would need to be sought
that could support the Secretariat but that would not have any responsibility directly for its
running. The choice of host, its agreed work programme, its operational structure and staffing
would be the responsibility of the Governing Board (see GBRCN MoU Document GP-PM0008).
The GBRCN will be advised by a Scientific Advisory Board, which will meet twice per year
and will support the GBRCN on strategy and operational issues, review proposals for further
development of the GBRCN and proposals for new participants. The GBRCN MoU
Document GP-PM-0008 lays down the basis for such operations and procedures.
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GBRCN Architecture
Given common standards for operations to deliver access to high quality materials, the
GBRCN must have the structure and capacity to fully take advantage of cross network
expertise and facilities. The GBRCN will provide an environment to achieve this facilitating
specialist groups or clusters to focus on delivering solutions to meet both BRC and its user
community’s needs. It will be an engine of innovation and burden sharing for efficiency and
delivering innovative solutions, it requires the structure to facilitate this. Through the
establishment of the GBRCN, countries are invited to constitute or reinforce their centres of
biological resources in order to reach the acceptable quality level for their certification at the
national level. This requires:
 A system to ensure the uptake of OECD BRC best practice;
 A common information linkage and data exchange system;
 BRC compliance with laws, regulations and standards in particular for access,
distribution and exchange of biological material, where applicable, through common
practices;
 The support of States, the scientific community and the private sector to advance
international co-operation and economic development.
The prime benefactor of GBRCN is the user who gets a single point of access to high quality
materials and a common understandable process from any cooperating BRC or culture
collection. They get a consistent level of service and better access to authentic and
reproducible materials in a transparent and traceable way. It will deliver a more
comprehensive service. They are confident that the materials are fit for purpose and the
assurance that national law, policies and procedures have been followed. The culture
collection that becomes a BRC and joins the GBRCN signs up to the GBRCN Cooperating
Agreement (Annex II of the GBRCN MoU). It consequently benefits by it being recognised
that they operate to international scientifically based quality criteria and thus have an
international mark of quality. Through the network they will have a raised profile, will share
tasks to avoid duplication of effort and will enjoy collaborative research and development.
The GBRCN is foreseen as an international body with its own small secretariat, governing
board and scientific advisory apparatus. However, to date the final form has yet to be decided.
This document outlines the best option, while the GBRCN MoU describes the individual
components. A number of options were discussed by the OECD BRC Task Force and a
consensus opinion was sought at the closing workshop in Paris 13-14 December 2007.
Consensus on the best alternative was not delivered, but the majority of participants at the
final workshop considered that an independent body operating through an existing
intergovernmental organisation (such as the Codex Alimentarius Commission-which operates
through FAO and WHO, or an independent body within OECD). The GBRCN Demonstration
Project considered this but soon recognised that a structure similar to GBIF with proven
instruments such as its MoU and its operational mechanisms proven to work was the best
way forward. Thus the GBRCN MoU Document GP-PM-0008 was developed to define the
structure of the GBRCN and includes Governing Board, Advisory Board, Secretariat Host,
Secretariat, Managing Director or Executive Secretary, Signatory Participants and the
Cooperating Entities i.e. the BRCs and Culture Collections.
Potential for GBRCN finances
The GBRCN would save considerable money by soliciting donations either from the State in
which it will be established or from established institutions to provide basic infrastructure. In
the latter case, a bidding process among interested suitors would precede the conclusion of a
separate agreement between the GBRCN and its Host in order to define their respective
responsibilities toward each other (see GBRCN MoU Document GP-PM-0008 Annex III for
suggested process). The Participants must be satisfied that the host country will not exert an
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excessive influence within the GBRCN simply by virtue of being its physical host. This
should not be confused with any natural, legitimate advantage that the country may have due
to its excellence in the field of biological resource management. Furthermore, it is
understood that the host country may derive some legitimate rewards, for example
international prestige and offer employment of local support staff.
GBRCN organisational chart
State Participants will want to derive maximum benefits from their financial contributions,
and they will be very reluctant to augment the national treasury of the host country, for
example, in the form of customs duties and income or value added taxes. Thus, the host
country will be well advised to offer the appropriate special status or exemptions that are
compatible with its national laws, and to specify the details of these concessions in the Host
Country Agreement. Details of host selection, the bidding process and support, facilities and
resources provided can be found in Annex III of the GBRCN MoU. The GBRCN model
business plan (GBRCN Document GP-WP-0068) provides the justification and detail for
operation and financial commitments.
GBRCN Operations
The GBRCN will be advised by a Scientific Advisory Board, which will meet twice per year
and will support the GBRCN on strategy and operational issues and review proposals for
further development of the GBRCN and proposals for new participantss. It is envisaged that
the GBRCN network, to work efficiently, would need to operate in clusters, either nationally
based to manage national needs i.e. implement specific national directives, or specialist
groups based around taxonomic groups or organism types or on specialist activities such as
molecular techniques, information technology or legal requirements. It is also envisaged that
existing regional groups would want to continue their activities together and thus contribute
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their knowledge and activity to the common good. Such regional groups would be the
European Culture Collections’ Organisation and the Asian Network for Microorganisms.
Some may operate within and some external to the GBRCN. The Governing Board advised
by its Scientific Advisory Board will agree a work programme, and its execution through the
GBRCN clusters or expert groups would be facilitated by the Secretariat.
The governance structure might comprise a Governing Board at the top, supported by any
necessary subsidiary bodies (such as a Scientific Advisory Board) and the Head of the
Secretariat. The purpose of the Governing Board is to provide a mechanism for making
collective decisions on the most important matters relating to the GBRCN. It would probably
meet once or twice per year to review progress and decide on major issues. The Governing
Boards’s primary responsibilities would include approving the GBRCN’s work programme
and annual budget and appointment of a Managing Director or Executive Secretary of the
Secretariat. Once established, it may adopt bylaws, which are rules to address more detailed
aspects of the GBRCN management (See paragraph 4 MoU).
The composition of the Governing Board would need to be agreed but it should represent the
funders. Subsidiary bodies such as the Scientific Advisory Board would involve the
participation of private parties and user representatives. The purpose of these bodies is to
submit recommendations to the Governing Board based on expert analysis. The groups might
also include States, accredited/certified BRC or even international organisations whose
missions complement the work of the GBRCN. This would better enable the Governing
Board to create synergies and avoid duplication through collaboration with such international
organisations. The MoU (Document GP-PM-00080 is the instrument of establishment which
addresses the basic voting issues and provides schemes adapted to their importance. Future
preparatory work could include drafting model rules of voting procedure for the Governing
Board to adopt in its Bylaws through a vote, but the Agreement should only include those
rules that are necessary for the Governing Board to make its initial decisions.
The Managing Director or Executive Secretary will be a key individual whose duties traverse
both the Governing Board and day to day role as the Chief Executive Officer of the GBRCN.
The success of the GBRCN will, in large measure, depend on his/her abilities as scientist,
manager, spokesperson and diplomat. The Governing Board will thus be strongly motivated
to recruit a person of high standing in the field which, in turn, will make it necessary to have
early agreement among the Participants about the salary range and other conditions of
employment. To attract a person of sufficient calibre, it may be necessary to offer an
employment contract of significant duration (e.g. 5 years) especially if the Director and
his/her family will have to move from another country.
Recruitment of suitable staff will be challenging, since professional excellence will be a
necessary, but not sufficient requirement for the GBRCN to be a success. There will be
considerations of geographical/national balance, international contacts and experience,
linguistic skills, familiarity with the laws and procedures of the Host country, etc. (see
GBRCN MoU).
The functioning of the GBRCN is dependent on the sustainability of the constituent BRCs
and Culture Collections. A generic business plan has been developed (GBRCN document
GP-WP-0024 Generic BRC Business Plan) to help. However, the wide variety of these
structures and their scope require differing financial models to support each. There are the
traditional lines of income such as culture supply charges, identification and characterization
of cultures and private, confidential or patent deposits. Among several potential new sources
of revenue is the generation of genomics and proteomics data that complement and add value
to biological materials themselves. The degree to which such activities may actually provide
support sufficient to ensure financial sustainability of a BRC is unproven. However, it is
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generally expected that most BRCs, whether single large national centres or smaller
distributed or specialized centres, require some degree of core funding by their respective
national governments. The kinds of funding sources include support from industry, grants
from agencies that support research, cost-recovery through fees-for-service, development of
databases and other tools that complement the core role of BRCs, and even funding from
charitable sources, especially those associated with public health or sustainable development.
The GBRCN network, although not addressing elements that could be competitive, will
support participant’s financial development. The funding of the GBRCN Secretariat must not
detract from sources supporting individual BRCs or collections.
The GBRCN infrastructure will support the development of BRCs in many ways most
importantly in the development of excellence. Table 1 shows the stages of collection
development leading to BRC status. One of the key work programmes and expert clusters of
the GBRCN will focus on such development and capacity building.
Table 1: Stages of collection development leading to BRC status
Status of collection
Basic level
Intermediate level
High level
Characteristics of collection status
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
BRC
•
•
Basic methods for Biological material preservation are
available
Basic documentation level
Sound facilities
Knowledgeable and skilled human resources
Good technologies in place
Electronic catalogues and data management
Operating to international criteria
Wide stakeholder involvement
Involvement into regional/national networking
Sustainable human resource training relevant to BRC domains
Collection quality management is in place
IPR regulations, MTAs; biosafety and biosecurity standards are
in place
Accredited or certified to the operational and quality ISO
standards
Clear management program and collection’s strategy in place
Sustainable fundraising mechanisms with governmental
support
Raised user awareness in the domain of Biological Resources
preservation
Regular monitoring and adjustment of collection needs
Leading activity in the regional/national/international
networking
High quality standards in operation and implementation of the
OECD best practice
Functioning according to the OECD instruments
The sustainability of a microbial domain focused GBRCN Secretariat
A general benefit of operating GBRCN through a Host is the provision of infrastructure and
practical services that the Secretariat will need to operate. It is in the interests of the GBRCN
Secretariat and Participants who contribute to the budget to have the Host provide these at the
lowest possible cost. Precise budget calculations for GBRCN depend on decisions that have
yet to be made, such as how many employees will be needed, their remuneration packages
and the location and quality of office facilities and meeting rooms. However, given its
foreseen functions, broad estimates are possible. Based upon the costs of other organisations’
secretariats and mainly upon the level of finance needed by the current GBRCN
Demonstration Project Secretariat, an initial Secretariat would need approximately €500,000
per year. To cover such costs, signatories to the GBRCN MoU would be expected to make
contributions based upon per capita GDP (see Annex I to the GBRCN MoU).
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The above contribution level would cover the estimated initial Secretariat and allow for its
expansion as new countries (Participants) join. The additional income will allow for funds to
be made available for some of the GBRCN work programmes or for support of capacity
building, in particular the support of BRCs in countries of developing economies implement
minimal best practices to enable legitimate access to their countries microbial diversity
currently not available to science.
There are a number of uncertainties that need to be taken into account:
Is a harmonised approach possible to create a legal operational framework?
Can common agreement on the sharing materials and data be reached?
Can a financial plan be devised to make the network sustainable?
Can a suitable mechanism be established to share tasks and co-ordinate activities?
Can a capacity building programme be supported?
Will Governments support this initiative?
These issues are not insurmountable and will be addressed by the GBRCN.
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Global Biological Resource Centre Network
STATEMENT TO THE BTWC SEVENTH REVIEW CONFERENCE
by ChrisQne Rohde
Leibniz-­‐InsQtut DSMZ-­‐Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH
A Biosecurity Code of Conduct for Biological Resource Centres
A Signal to strengthen the global implementaQon of the BTWC
Mr. President, Excellencies, DisQnguished RepresentaQves, Ladies and Gentlemen,
I would like to express my graQtude to you for the opportunity to make a statement on behalf of the GBRCN, this is the Global Biological Resource Centre Network. The Final DeclaraQon of the Sixth Review Conference in regard to ArQcle IV reaffirmed the commitment of States ParHes shall take the necessary naHonal measures under this ArHcle and that necessary naHonal measures under this ArHcle … would strengthen the effecHveness of the ConvenHon. We welcomed the call that you made for States ParHes to adopt, in accordance with their consHtuHonal processes, legislaHve, administraHve, judicial and other measures, including penal legislaHon, designed … to ensure the safety and security of microbial or other biological agents or toxins in laboratories, faciliHes, and during transportaHon, to prevent unauthorized access to and removal of such agents or toxins . In 2008, the MeeQng of States ParQes devoted several working sessions to naHonal, regional and internaHonal measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins (agenda item 6) and to oversight, educaHon, awareness raising and adopHon and/or development of codes of conduct with the aim of prevenHng misuse in the context of advances in bio-­‐science and bio-­‐technology research with the potenHal of use for purposes prohibited by the ConvenHon (agenda item 7). We especially endorse the outcome of the MeeQng of States ParQes in 2008 when you recognized that biosafety and biosecurity measures contribute to prevenHng the development, acquisiHon or use of biological and toxin weapons and are an appropriate means of implemenHng the ConvenHon. In order to take such measures, it is necessary to enhance awareness and create a biosecurity-­‐conscious culture. We noted that in your MSP 2008 report biosecurity refers to the protecHon, control and accountability measures implemented to prevent the loss, the9, misuse, diversion or intenHonal release of biological agents and toxins and related resources as well as unauthorized access to, retenHon or transfer of such material. And furthermore, agreed on the value of …applying appropriate risk assessment and risk management strategies. The problem in the life sciences is the dual-­‐use potenQal of bio-­‐resources, associated data and know-­‐how. These can be misused maliciously whether by non-­‐States actors/terrorists or by States. Shortcomings in the effecQve implementaQon of the ConvenQon have their origin in ignorance and lack of concern. Consequently, careful export control, tracking of biological material and observing all transport requirements including the RecommendaHons on the Transport of Dangerous Goods-­‐Model RegulaHons (16th rev. ed.) are essenQal. It includes security plans for transport of High Consequence Dangerous Goods like infecQous substances Category A, UN 2814/UN 2900. There is no doubt that the WHO Biorisk management Laboratory biosecurity guidance (2006) is an invaluable tool to implement biosecurity. The document uses the expression valuable biological materials poinQng out strongly the value of biological resources for research and progress. This alone is not enough to implement effecQve biosecurity: adequate prevenQve measures help avoid reacQve measures. Biosecurity on the whole is highly complex and it is oBen difficult for scienQsts to perceive the dual-­‐use potenQal of their profession and work. ScienQsts tend to believe wholly in the bonafide use of bioresources, associated data and know-­‐how. Know-­‐how transfer does not seem criQcal. The scienQfic world proclaims total freedom of research and world-­‐wide exchange is essenQal. But, biosecurity needs to become an integral part of human acQvity in the life sciences. Several internaQonal, regional and naQonal scienQfic associaQons of the life sciences have developed Codes of Conduct or Ethical Codes; generally biosecurity plays an important though not outstanding role in those Codes. ScienQfic best pracQce primarily addresses the ethics of the science undertaken; special biosecurity Codes are infrequently found. Therefore, several Biological Resource Centres decided to elaborate a pracQce-­‐related Code of Conduct devoted specifically to biosecurity in order to protect their faciliQes and staff and the world’s freedom: The OECD Directorate for Science, Technology and Industry and the Task Force on Biological Resource Centres (BRCs) realized as early as 1999 that there was a gap to be filled to cover bio-­‐legislaQon (www.SourceOECD.org). In 2007, the OECD published the Best PracHce Guidelines on Biosecurity for BRCs including detailed QualitaHve Risk Assessment and Risk Management PracHces. This document postulated the development of a Biosecurity Code of Conduct. With support by the European Commission, the project EMbaRC ( European ConsorQum of Microbial Resources Centres) developed the Biosecurity Code of Conduct (CoC) as it is presented here, in cooperaQon with the GBRCN, the Global Biological Resource Centre Network, an umbrella iniQaQve for many microbial resource collecQons around the world. GBRCN has dedicated a task force to address biosecurity, the dual-­‐use problem, export controls and the BTWC. Your MSP 2008 report agreed on the value of building networks between scienHfic communiHes and academic insHtuHons… for appropriate risk communicaHon strategies and tools. GBRCN is such a network. Its members are legal enQQes and providers of biological materials which fulfill their mission of delivering bio-­‐
resources to authorized recipients within their countries and across borders and conQnents.
As we recognize the present and future value of the effecQve naQonal implementaQon of the BTWC with its high global relevance, and recognizing the rapid scienQfic and biotechnological developments, we would like to express to the States ParQes that the CoC presented here will add value to the objecQves of the BTWC. The aim of the CoC is to prevent microbial resource centres from directly or indirectly contribuQng to malicious misuse of biological agents and toxins, including the development or producQon of biological weapons and shall promote a basic ethical understanding of science compliant with the BTWC. We also consider that such a generally applicable type of a Code can substanQally help all States ParQes because awareness raising is absolutely crucial in the scienQfic world. The Code as presented is far-­‐reaching, going beyond the GBRCN community. Indeed most countries have microbial resource collecQons, with different holdings, infrastructure and risk potenQal. However, BRCs are not only biological resource centres but also biological research centres.
The GBRCN require that this CoC shall be implemented by BRCs all over the world. It is designed in such a manner that similar scienQfic and bio-­‐medical insQtuQons and, on a higher level, scienQfic associaQons and socieQes can use the CoC to demonstrate their will to strengthen the BTWC. In conclusion, our message and recommendaQon to the Seventh Review Conference is that States ParQes should, as part of their consideraQon of improving the naQonal implementaQon of the ConvenQon, agree to adopt a comparable Code of Conduct for their naQonal microbial resource collecQons and other insQtuQons in the life sciences because of the awareness raising focus on biosecurity that it provides. We recommend that States ParQes acQvate and involve their legal authoriQes in a top-­‐down process of communicaQon with their life sciences insQtuQons. Thank you again for the opportunity to give a statement on behalf of GBRCN
A poster will also be presented and provides further informaQon on details of the CoC, on projects and iniQaQves involved. Copies of the CoC and accompanying documents are available at the poster. This GBRCN statement was prepared by
ChrisBne Rohde, Leibniz-­‐InsQtut DSMZ-­‐Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Braunschweig, Germany, chr@dsmz.de
in associaQon with:
Dagmar Fritze, Leibniz-­‐InsQtut DSMZ-­‐Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Braunschweig, Germany
Dunja MarBn, Leibniz-­‐InsQtut DSMZ-­‐Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Braunschweig, Germany
David Smith, CAB InternaQonal, Surrey, United Kingdom
Joost Stalpers, CBS-­‐KNAW Fungal Biodiversity Centre, Utrecht, Netherlands
Joerg Overmann, Leibniz-­‐InsQtut DSMZ-­‐Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Braunschweig, Germany
Geneva, December 2011
A DEMONSTRATION PROJECT WITH A FOCUS ON MICROORGANISMS
FINAL REPORT ON THE GBRCN
DEMONSTRATION PROJECT
Period of Project:
30.11. 2008 - 30.11. 2011
ISBN 978-3-00-038121-8